Longevity Industry Jobs

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize trans-formative, durable, precision genomic medicines for many diseases.

We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.

Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world. If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Lead/Train a clinical MFG team in a clean room environment while fully gowned following GMP guidelines and using aseptic technique.
• Generate, revise, review and approve SOPs, batch records and other quality documents to support internal manufacturing projects and ensure all documents are maintained to accurately reflect the most current process
• Lead troubleshooting of process and equipment problems with manufacturing, process development and quality teams
• Operate instrumentation required for cell manufacturing and gene editing.
• Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed.
• Work in a Biological Safety Cabinet for open processing operations.
• Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation.
• Maintain orderly lab space.
• Maintain sufficient inventory of supplies and reagents for performance of duties. Clean and maintain laboratory equipment in good working order.
• Prepare solutions and culture media as appropriate.
• Work in compliance with all appropriate laboratory regulatory and safety requirements

Requirements

Knowledge, Skills & Capabilities:

• Must have experience with Cell Therapies
• Must have experience working in a GMP environment
• Must have technical knowledge to work as a liaison between MFG and Process Development
• Self-motivated and detailed-oriented. Willing to be trained to new techniques
• Ability to read and understand Standard Operating Procedures
• Preferred experience with gene editing processes
• Preferred experience with GMP document creation/revision
• Preferred experience with Quality Management Systems
• Strong organizational skills and attention to detail with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
• Good communication skills and the ability to work independently, and as part of a team
• Preferred experience with Excel and Microsoft Office applications

Education & Relevant Work Experience

• Bachelor’s degree with 2-4 years of relevant experience
• High School diploma and 4+ or more years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3+ year of GMP Manufacturing experience will be considered
• Ability to pass sterile gowning qualification required

Preferred

• Previous cleanroom or cGMP experience is highly desirable
• Fill/finish or aseptic technique training strongly preferred

Shift Differential Pay

Editas Medicine offers Premium Pay in the form of a 10% shift differential added to the hourly rates of employees who are regularly scheduled to work second shift, which is defined as a work shift falling between the hours of 2:00 – 10:00 PM (local time). This differential will be removed for employees who move to a shift that occurs during regular business hours.

Physical & Travel Requirements

• Must be willing and able to travel between Cambridge and Waltham locations

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed.
• Work in a clean room environment while fully gowned following GMP guidelines and using aseptic technique.
• Work in a Biological Safety Cabinet for open processing operations.
• Operate instrumentation needed for cell manufacturing.
• Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation.
• Maintain orderly lab space.
• Maintain sufficient inventory of supplies and reagents for performance of duties. Clean and maintain laboratory equipment in good working order.
• Prepare solutions and culture media as appropriate.
• Work in compliance with all appropriate laboratory regulatory and safety requirements.
• Complete revisions of documents and procedures to reflect all cGMP’s.

Requirements

Knowledge, Skills & Capabilities:

• Experience with primary cell culture, preferably with human cells
• Experience working in a GMP environment is preferred
• Self-motivated and detailed-oriented. Willing to be trained to new techniques
• Ability to read and understand Standard Operating Procedures
• Attention to detail
• Good communication skills and the ability to work independently, as well as part of a team
• Preferred experience with GMP document creation/revision
• Preferred experience with Excel and Microsoft Office applications

Education & Relevant Work Experience

• Bachelor’s degree with 0-2 years of relevant experience
• High School diploma and 2 or more years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience will be considered
• Ability to pass sterile gowning qualification required

Preferred

• Previous cleanroom or cGMP experience is highly desirable
• Fill/finish or aseptic technique training strongly preferred

Shift Differential Pay

Editas Medicine offers Premium Pay in the form of a 10% shift differential added to the hourly rates of employees who are regularly scheduled to work second shift, which is defined as a work shift falling between the hours of 2:00 – 10:00 PM (local time). This differential will be removed for employees who move to a shift that occurs during regular business hours.

Physical & Travel Requirements

Must be willing and able to travel between Cambridge and Waltham locations

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Shift Differential Pay

Editas Medicine offers Premium Pay in the form of a 10% shift differential added to the hourly rates of employees who are regularly scheduled to work second shift, which is defined as a work shift falling between the hours of 2:00 – 10:00 PM (local time). This differential will be removed for employees who move to a shift that occurs during regular business hours.

Editas Medicine is seeking a Senior Specialist, QC Sample Management, who can support the activities related to sample management/sample submission for internal testing and testing performed at contract organizations. This person will also coordinate testing related activities and support efforts to obtain and review results. The ideal candidate will have experience with a variety of analytical testing methods including, but not limited to HPLC, UV, CE, Bioassay, PCR, Gel Electrophoresis and compendial testing. Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment.

Key Responsibilities

• Coordination of sample shipments for product release and results tracking
• Reviews QC testing data and/or Biologics analytical methods generated by vendor test labs.
• Supports vendor OOS/ATI/Investigations, verifies that data meets current specifications, generates COA(s), and tracks cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls.
• Assists in the planning of basic unit operations
• May communicate with vendor test laboratories.
• Works with department peers to execute well defined assignments.
• Prepares protocols/reports as appropriate/necessary
• Reviews and interprets data with support from a supervisor
• Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility
• Assists with method transfer and method validations at vendors as appropriate.
• Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems
• Downloads data from vendor sharepoints/databases/LIMS.

Requirements

• Bachelor’s degree in Chemistry or Biology with 5+ years of Quality Control or Analytical Development experience in Biopharma.
• Analytical and problem-solving Skills. Able to troubleshoot routine issues or problems using appropriate information
• Working knowledge of GMP compliance
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The In Vivo Gene Editing and Critical Component Process Development team in the Process and Analytical Development (PAD) Department is seeking a highly motivated and experienced Process Engineer for the development of critical gene editing components [e.g. CRISPR-Cas nucleases, Ribonucleoprotein (RNP), etc]. The successful candidate will support the design and execution of process development projects, coordinating with process and analytical experts within PAD and cross-functionally in Technical Operations, Manufacturing, Quality, Research and Discovery to advance Editas’ ex vivo and in vivo gene editing program. This is a new position created to expand the team’s technical capability in late-stage drug substance development.

Key Responsibilities & Accountabilities

• Lead or support experiments in process optimization, scale-down model qualification and process characterization for protein and RNP products
• Support representative protein and RNP material generation for process development and analytical development (AD)
• Collaborate with AD to generate data for formulation studies, stability studies, and characterization of drug substance and/or drug product
• Provide technical support for Process Tech Transfer, engineering and cGMP manufacturing campaigns (e.g. batch record review, change control management, deviation investigation, etc) in collaboration with other CMC line functions as needed
• Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner. Write SOP, work instructions and batch records and may contribute to regulatory document drafting and review
• Compile and present data and assist in authoring and reviewing of batch records, work instructions, technical reports, and supporting procedures.
• Cross-train personnel on processes, and provide guidance to junior team members, as required
• Maintain abreast latest industry trends for microbial protein manufacturing processes and product knowledge
• Contribute to equipment procurement, setup and training

Requirements

Knowledge, Skills & Competencies

• Strong technical expertise and meaningful hands-on experience in microbial fermentation process development, scale-up and/or manufacturing in a drug development setting are required
• Proficient bioreactor/fermenter operation skills with solid understanding of fermenter control systems and scale-up principles are required
• Working knowledge of biologics purification techniques (e.g. UFDF, depth filtration, Chromatography) is a must
• Knowledge and experience with QbD and common risk assessment tools for process development and characterization are highly preferred
• Experience in Technical Transfer of GMP manufacturing processes for biologics is a plus
• Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment
• Proficient verbal and written communication skills
• Basic understanding of analytical methods utilized in microbial manufacturing process and drug development life cycle

Required Experience

• Bachelor’s experience in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 6+ years of relevant experience or Master’s with 4+ years of experience.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas is seeking a Quality Control Senior Analyst to join the Quality Control team and play a significant role in the support of our product pipeline.

This position reports to the QC Manager, Internal Operations.

This position will be responsible for performing a variety of QC testing including, but not limited to, using Flow Cytometry, FTIR, Osmometer, Cellometer, NanoDrop, ImageStream, StemVision, UV-VIS, HPLC/UHPLC, qPCR/ddPCR, Plate reader, pH/Conductivity, Gel Electrophoresis and Compendial Methods.

This position will also be responsible for Method Validation and Transfer from Internal Analytic Development and/or External Testing Laboratories to Quality Control Internal at Editas Medicine.

This position will work at both QC sites in Cambridge and Waltham facility, MA.

Key Responsibilities & Accountabilities

• Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Visual Appearance Inspection, Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA by Plate Reader, Colony count by StemVision, sickling reduction by ImageStream Analysis, HPLC/UHPLC, qPCR/ddPCR, etc.
• Responsible for drafting, executing and reporting Method Validation and Transfer Protocols.
• Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required.
• Responsible for change controls, OOS and deviations, as required.
• Assist sample shipment and result collection of external tests.
• Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving.
• Perform other duties, as assigned.

Requirements

Knowledge, Experience, Skills & Capabilities:

• Hands-on experience minimally on following equipment/assays, but not limited to: Visual Appearance Inspection, pH, FTIR, Osmolality, K2 cellometer, Flow Cytometer, NanoDrop, Plate reader, HPLC/UHPLC, qPCR/ddPCR, ImageStream and StemVision.
• Working experience on method validation and transfer.
• Working experience in analytical/QC environment.
• Working experience in compliance with cGMP’s, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities.
• Ability to work independently with skills for multi tests/projects.
• Ability to collaborate, communicate, and work effectively in a team-oriented.
• Good verbal and written communication skills.
• Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Traning systems.

Education & Relevant Work Experience

• Bachelor’s or Master’s degree in biology, chemistry or other life science.
• At least 5-8 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The Director, Clinical Compliance will possess knowledge and understanding of ICH GCP, essential regulatory requirements and guidelines and requirements impacting all aspects of drug development and regulatory inspection activities. The individual in this role will also have significant knowledge and understanding of Clinical Development policies and procedures. The Director, Clinical Compliance will provide leadership and expertise to ensure the delivery of regulatory requirements related to Clinical Compliance and Inspection Readiness activities. The successful candidate will be skilled at both understanding and applying internal procedures and policies as well as local and global regulations and processes as trials advance through development. The position requires a collaborative partnership with cross-functional team members throughout the organization.

Key Responsibilities

• Lead and retain accountability for the development, alignment, and guidance across the organization regarding compliance regulations and applicable processes and practices including the authoring and review of company policies and procedures.
• Responsible for managing the Clinical Compliance program, develop and maintain a written compliance plan and annual evaluation of the plan’s effectiveness; ensure all required elements of a compliance program are addressed.
• Oversee investigations(CAPAs) relating to reports of known or suspected violations of the compliance program.
• Ensure that compliance issues associated with clinical audits or inspections are properly evaluated and are effective action plans are developed in response to audit discoveries and compliance violations.
• Advise management on the company's compliance with laws and regulations through detailed reports.
• Implement clinical oversight program to maintain EDITAS compliance with ICH E6 R2

Requirements

Qualifications

• Bachelor’s degree required. Master’s degree in Clinical Sciences, Public Health, Healthcare Administration highly preferred.
• Minimum of 8 years of experience in clinical research with at least 6 years of direct responsibility and experience in clinical compliance
• Excellent written and oral communication skills exemplified by timely follow-up; meeting participation; effective negotiating skills; the ability to summarize and frame issues, discussions, conclusions; and development of effective communication plans.
• Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
• Ability to manage multiple projects in a fast-paced environment
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

This newly created position of VP Pharmacovigilance will lead the safety and pharmacovigilance (PV) activities for Editas’ expanding clinical portfolio supported by our unique gene editing platform. The position represents a key partner in establishing and driving forward tactical plans to enable Editas to deliver on its mission to translate the power and potential of genome editing into a broad class of in-vivo and cellular treatments that transform lives of people living with serious diseases.

The qualified candidate will lead PV team responsible for safety of clinical studies of all therapeutic area in the pipeline, participate clinical development plan, clinical study design and execution and regulatory submission. The PV team will lead safety data analyses, the identification and investigation of potential safety signals, development of risk management and pharmacovigilance plans, safety related regulatory reporting to ensure compliance and timely reporting of adverse events in accordance with the regulatory requirements of the applicable Regulatory Agencies.

The individual will report to the Chief Medical Officer and will operate in a matrixed role interfacing closely with Clinical Development, Biometrics, Clinical Operations, and Regulatory, with support from external CROs.

The Successful Candidate Will

• Be the leader of pharmacovigilance for Editas’ clinical programs in partnership with Clinical Development, Biometrics, Clinical Operations and Regulatory Functions.
• Lead the safety and risk management of the clinical studies; monitor and analyze the safety data
• Lead the development of risk management plans and associated documents to ensure that study-specific and health authority reporting requirements are met and that workflow between contract research organizations (CROs) and Editas is delineated
• Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with Regulatory Affairs and/or Contract Service Provider
• Oversee and manage PV vendor(s) to ensure regulatory compliance and contractual obligations are met
• Reviews the safety sections of clinical documents, including protocols, annual reports, investigational brochures, and other documents
• Oversees SAE database reconciliation in collaboration with Data Management
• Ensures compliance with global regulations and ICH guidelines to meet all drug safety and pharmacovigilance reporting requirements
• Oversee preparation, development, implementation and maintenance of company SOPS and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements.
• Knowledge of current US and international regulatory requirements; Maintain current with applicable PV global regulations, and industry guidelines. Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
• Serve as the Pharmacovigilance subject matter expert for internal audits and FDA and global regulatory inspections and remediate any pharmacovigilance deficiencies found during regulatory or internal audits. Identify and follow-up on corrective action plans arising from audits and inspections
• Implements PV quality management system including the identification and authoring of required procedural documents
• Collect, analyze metric reports related to ICSRs, aggregate reports to ensure the systems and processes are compliant with the study specific plans, SOP and PV regulations
• Author, review and approve SOPs as required
• Escalate critical and major PV gaps to the management to ensure appropriate action
• Support and participate in PV training of employees as needed
• Demonstrated experience in communicating across several cross functional groups managing business process outsourcing vendors and relationships.
• Previous experience in collection and handling metrics related to PV operations
• Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
• Excellent written and verbal communication skills to a variety of levels and teams, internally and externally.
• Demonstrated persuasion, influencing and negotiation skills.
• Ability to operate objectively and independently as a leader and as a member of matrix teams, as required
• Effective team player, with proven ability to effectively lead projects and teams to successful conclusion

Requirements

Knowledge, Skills & Capabilities:

• Hands on and motivated leader to drive the risk management and the clinical programs
• Demonstrated ability to influence across a matrix structure, and to collaborate in a cross-functional environment
• Highly organized and proficient in working in matrix team to support business and clinical program needs
• Provides motivational leadership to the organization and improve its performance
• Strong problem-solver and business acumen.
• Strong interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously

Education & Relevant Work Experience

• Demonstrated ability as a line function manager
• Exposure to and management of significant accelerations and challenges in clinical programs.
• MD or MD PHD with 15 years or more in industry with majority in Pharmacovigilance with prior experience of leading Pharmacovigilance for multiple clinical development programs
• Experience or high comfort level in supporting clinical programs across multiple therapeutic areas, and bridging late to early development, familiarity with gene and/or cell therapy a plus
• Ability to work with the Senior Executive Team and other external audiences such KOLs, regulatory bodies
• Solid knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
• Strong knowledge of MedDRA and common safety database.
• Demonstrated leadership and technical capabilities with the ability to simultaneously manage multiple different projects.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas Medicine is seeking a highly motivated and dynamic leader to lead the development of genome editing medicine to treat hematological diseases. This individual will lead a team of scientists to perform research ranging from early discovery to supporting regulatory filings. The individual will actively participate in program teams and collaborate effectively across functions; contribute to advancing Editas’ EDIT-301 program for beta hemoglobinopathies to commercialization; and leading effort in developing milder conditioning regimen and in vivo HSC editing. The successful candidate shall demonstrate a proven track record in development experience with biologics, nucleic acid-based, or gene therapy products through IND/BLA and possess a solid understanding of FDA/EMA guidelines. This individual will be collaborative, goal-oriented, and timeline sensitive while maintaining high quality output.

Responsibilities

• Manage a diverse team of scientists to perform research supporting development of HSC-based therapies from early discovery to regulatory filing.
• Lead the discovery effort to identify milder conditioning regimen to improve patient experience and access to EDIT-301
• Lead the discovery effort for in vivo editing of HSCs to treat hematological diseases.
• Develop project strategy, understand timeline and deliverables, plan, and coordinate project work with functional stakeholders.
• Contribute to building the product strategy for EDIT-301 including life-cycle management and path to commercialization.
• Effectively manage CROs, academic collaborators, and KOLs.
• Establish SOPs, write prospective protocols, author study reports and regulatory documents, assist patent filing, and contribute to business development activities.
• Serve as a technical and scientific resource for junior staff.
• Skillfully manage diverse team interactions.
• Consistently role model Editas values and behaviors as a people manager to positively influence our culture and engagement.

Requirements

• Ph.D in hematology or related field of study with minimum of ten years of working experience, including strong track record of hands-on experience in development of gene and cell therapy in pharmaceutical and/or biotechnology industry.
• Solid understanding of hematopoietic stem cell biology is required.
• Working experience with lipid nano particles for targeted delivery in vivo is highly desirable.
• Familiarity with FDA and EMA guidance for cell and gene therapy and experience with IND-filing.
• A minimum of five years managerial experience that demonstrates effective leadership across a cross-functional setting.
• Ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audience both internal and external to Editas, excellent written skills.
• Ability to conduct high-quality research and execute research plans in a timely and organized manner.
• Must be able to adjust quickly to changing priorities.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas Medicine is seeking a highly motivated and skilled scientist with in-depth understanding of hematopoietic stem cell and red cell biology to join the Hematology team to develop genome editing medicine to treat hematological diseases. This individual will lead a small team of research associates to perform studies to support life cycle management for EDIT-301, Editas’ lead clinical asset for the treatment of beta hemoglobinopathies. The individual will actively participate in research teams and collaborate effectively across functions; contribute to advancing Editas’ EDIT-301 program to commercialization; and support effort in developing milder conditioning regimen and in vivo HSC editing. This individual will be collaborative, goal-oriented, and timeline sensitive while maintaining high quality output.

Responsibilities

• Manage a small team of research associate/associate scientists to perform research supporting development of HSC-based therapies from early discovery to regulatory filing.
• Lead discovery efforts for follow-on EDIT-301 therapies including identifying milder conditioning regimen to improve patient experience and access to EDIT-301
• Support discovery efforts for in vivo HSC editing approach.
• Establish SOPs, write prospective protocols, author study reports and regulatory documents, assist patent filing, and contribute to business development activities.
• Design and execute in vivo and in vitro experiments, maintain detailed record electronically in accordance with Editas’ policy, analyze data and present at internal and external meetings.
• Manage interactions with vendors, CROs, KOLs, and academic collaborators.
• Support project strategy development, manage research timeline and deliverables, plan, and coordinate project work with functional stakeholders.
• Serve as a technical and scientific resource for junior staff.
• Manage diverse team interactions. Be a dedicated peoples’ manager to positively influence our culture.

Requirements

• Ph.D in hematology or related field of study with minimum of three years of working experience, including strong publication records.
• Must have hands-on experience working with mouse models and is proficient in dosing, tissue harvest, and processing.
• Must be proficient in cell-based assay development and molecular techniques.
• Solid understanding of hematopoietic stem cell biology is required. In-depth understanding of red cell biology is a plus.
• Hands-on experience with gene editing technologies is a plus.
• Hands-on experience in development of gene and cell therapy in pharmaceutical and/or biotechnology industry is desirable.
• Working experience with lipid nano particles for targeted delivery in vivo is highly desired.
• Ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audience both internal and external to Editas, excellent written skills.
• Ability to conduct high-quality research and execute research plans in a timely and organized manner.
• Must be able to adjust quickly to changing priorities.
• Effective communicator.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas Medicine is seeking a detail- and goal-oriented Operations Manager to join the Translational Research and Operations Team. The Operations Manager will be responsible for the management of bioanalytical CROs involved in clinical stage gene and cell therapy programs. The Operations Manager will ensure that bioanalytical assays (including non-GLP, GLP, GCLP, CLIA-regulated assays) are successfully transferred, qualified, or validated at CROs and implemented for non-clinical and clinical study support. The individual will work closely with clinical operations, data management and other stakeholders to ensure critical timelines are met by vendors. The individual will be responsible for communicating with bioanalytical CROs to track patient samples, review data output, and review and resolve any sample collection issues. The ideal candidate will have bioanalytical assay development, vendor oversight, and project management experience with clinical programs.

Key Responsibilities

• Manage CROs to ensure that bioanalytical assays are successfully transferred, qualified, or validated at CROs and implemented for non-clinical and clinical study support.
• Collaborate with Clinical Operations to track site initiation, patient enrollment, and sample collections to ensure timely communication with bioanalytical CROs for upcoming sample shipment and analysis need.
• Request, coordinate, and track shipments for real time, batch, and specialty sample analyses.
• Coordinate sample analysis and data transfer with the data management team to ensure timely TLF generation.
• Answer queries from sites on upcoming collections through ClinOps.
• Review any relevant ICF queries with ClinOps.
• Review LSA/QRC/Lab manual documents for correct content on sample collection, assay execution, and data transfer.
• Review DTA in collaboration with data management to ensure all parameters and results are captured correctly.
• Review data and reports for accuracy.
• Manage study documentation at bioanalytical CROs such as study plan amendments, stability testing, and clinical sample testing plan.
• Coordinate with assay SMEs to lead assay specific discussions with CROs.
• Document, review, and resolve sample collection issues with ClinOps.
• Work with the Finance team to implement and track the Bioanalytical CRO budgets.

Requirements

Minimum Requirements:

• Bachelor’s degree with 6-8 years of experience in an industry setting.
• 5+ years hands-on experience managing CRO activities.
• Experience with the development of bioanalytical assays preferred.
• Hands-on experience working in a regulated (CLIA / GLP / GCLP) environment is a plus.
• Project management experience and familiarity with project management tools such as Smartsheet and ClinTrak desirable.
• Excellent communication and presentation skills as well as organizational aptitude.
• Attention to detail and ability to work under tight timeline.
• Ability to work cross functionally efficiently, influence without authority, and manage conflict

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Perform monthly close activities, including preparation of journal entries, reconciliation of various balance sheet and P&L accounts, including cash, investments, AR, intercompany, leases and various month-end R&D accruals
• Monitor, track, and record transactions related to license and collaboration agreements
• Provide accounting support for external and internal audit requests, including SOX404b testing
• Drive, develop, and maintain the Company's narratives and internal control matrix. Work with key processes owners to educate them on internal controls.
• Ensure all accounting policies and procedures are documented and in line with relevant GAAP standards and regulatory requirements
• Evaluate assigned processes and recommend improvement to maximize efficiencies and ensure conformity to internal policy and procedure and regulatory requirements
• Collaborate across the finance team and other operational departments on cross-functional initiatives including partnering with FP&A on budget-to-actual analyses
• Assist in preparation of quarterly and annual SEC filings, financial statements, and other management reports
• Assist with accounting/finance process improvements
• Assist with payroll and equity administration as needed
• Assist with the preparation of stock based compensation expense in accordance with ASC 740
• Prepare certain schedules for the Company's corporate tax provision and returns
• Assist with ad hoc projects as required

Requirements

Knowledge, Skills & Capabilities:

• Strong organizational skills and detail-oriented self-starter with the ability to work independently to meet deadlines
• In-depth knowledge of and ability to apply generally accepted accounting principles and concepts
• Proficient in Excel, experience with Oracle Fusion, Equity Edge and ADP a plus
• Must be a critical thinker and problem solver able to question what is and recommend what should be
• Career minded, team player with a strong work ethic and the ability to lead
• A collaborator who communicates in an open, clear, complete, timely, and consistent manner

Education & Relevant Work Experience

• Bachelor's degree with a concentration in Accounting
• CPA qualified is strongly preferred
• Experience implementing significant process and technology improvements, significant functional experience specifically in accounting operations in a publicly traded company environment
• Minimum of 3-5 years of related public company experience including internal controls or a big 4 accounting firm with increasing level of responsibility and demonstrated leadership skills
• Prior life science experience preferred, including knowledge of clinical and manufacturing accrual process.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Develop, execute, and transfer cell-based assays to support gene-modified cell therapy programs
• Work collaboratively cross-functionally with internal project teams as well as external CDMOs
• Analyze and present data within the organization
• Share responsibility in maintaining lab equipment and reagent inventory
• Maintain an electronic lab notebook and contribute to supporting documentation

Requirements

Knowledge, Skills & Capabilities:

• Experience in performing molecular biology techniques such as ddPCR and RT-qPCR
• Experience with running flow cytometry assays
• Experience with mammalian cell culture
• Experience with development and qualification of cell-based assays a plus.
• Results-driven with excellent attention to details
• Excellent written and oral communication skills
• Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
• Ability to work collaboratively in a team-oriented, multidisciplinary environment
• Experience writing/editing standard operating procedures and reports (preferred)
• Knowledge of CRISPR/Cas9 gene editing technologies (preferred)

Education & Relevant Work Experience

• M.S. in cell/molecular biology, biotechnology, biomedical engineering, or related field with 0-2 years of relevant experience (3+ years for Associate Sci I)

Or

• B.S. in cell/molecular biology, biotechnology, biomedical engineering, or related field with 2+ years of relevant experience (5+ years for Associate Sci I)

Preferred Requirements

• Knowledge of CRISPR/Cas9 gene editing technologies.
• Development and/or technical transfer of GMP test methods for biologics.
• Technical skills: mammalian cell culture, immunoassays including ELISA, MSD, flow cytometery, and molecular biology techniques—qPCR, ddPCR

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Supports the clinical team in the overall management of studies, including planning, execution and closeout of one or more clinical trials
• Assists with site management activities, including review of monitoring reports and tracking of site visits
• Communicates effectively with internal and external study personnel (investigative staff, vendors, CROs etc)
• Supports the project team with planning and preparation for investigator meetings and conferences
• Assists the study team with preparation of external and internal documentation for assigned trials and provides study status updates as requested
• Participates in vendor identification and management (e.g., CROs, IVRS, Central Labs, etc) as needed
• Assists with the development of vendor and site budgets and supports invoice and budget activities
• Has ownership of updating internal and external systems in a timely manner (CTMS, clinicaltrials.gov) and the maintenance of the Trial Master File
• Maintain site, vendor, team, and other contact lists and assists with the management of tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up to date
• Drive and prepare a quality response to regulatory authorities by coordinating all cross functional departments to ensure on time completion.
• Participates in clinical operations initiatives and programs as assigned
• Identifies, addresses and communicates quality and compliance concerns to the Sr. Director Clinical Quality
• Assist in development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities
• Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes
• Assist the study team with review all site regulatory packages during study start-up to approve for Investigational Product release
• Assist the data manager with data monitoring such as tracking of SAEs and protocol deviations as needed
• Supports the management of tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up-to-date
• Communicate with management and clinical trial teams to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status
• Review study plans and other clinical documentation
• Communicate with study sites regarding regulatory, start up and enrollment activities
• Provide oversight of CROs
• Coordinate and track site training for vendor specific study tasks
• Drive and manage clinical operations vendor deliverables
• Interface with CMC for shipment of drug to site pharmacies
• Receives minimal guidance and works independently
• Develop patient facing recruitment materials
• Develop work instructions for site staff
• Contribute to department documentation such as forms, templates, SOPs
• Prepare of protocol amendments for submission to IRBs, update effected study documents to align with changes submit to CRO for distribution to sites
• Prepare responses to IRB questions
• Identify, address, and escalate (potential) obstacles to project timelines, cost, and quality
• Tracking of regulatory submissions, drug shipment, enrollment of subjects, regulatory document flow, site start up tasks, contracts, and invoicing information
• Update SOWs for vendors as needed
• Creation of storyboards to document study issues
• Coordinate IDMC interactions through communication with CRO
• Coordinate stakeholders from closely related functions

Requirements

Knowledge, Skills & Capabilities:

• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
• Demonstrates well-developed instincts and problem-solving skills
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• An understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
• Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy
• Experience with phase 1-3 clinical drug development trials
• Strong communication, organizational and interpersonal skills are required
• Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities

Education & Relevant Work Experience

• BA/BS degree required
• 1-3 years’ experience in the biotech industry and clinical drug development or clinical trial execution

Physical & Travel Requirements

~10% travel on average- for IMs, site visits, and other team meetings

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Manages stability sample submissions to internal and external testing labs.
• Manages tracking of the stability sample pull schedule per approved protocols.
• Performs data review, interprets results, compares results to approved specifications, generates Certificate of Analyses (COAs) and enters data into database.
• Trends stability data for critical components, drug substance and drug product using statistical software. Experience with JMP is preferred.
• Routinely communicates stability trends and changes to expiration dating to CMC Teams.
• Prepares protocols and reports and initiates document workflows in eDMS. Experience with Veeva preferred.
• Prepares stability sections for IND, IMPD, BLA and MAA as requested.
• Collaborates with peers to execute well defined assignments.
• Identifies and communicates technical problems anddata discrepancies.
• Supports OOS, OOT, and Investigations and works with QA on associated deviations, CAPAs, and change controls. Assists with method transfer and method validations at vendors as appropriate.

Requirements

Knowledge, Skills & Capabilities:

• Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
• A strong understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations.
• Previous experience in Quality Control and specifically Stability is required.
• Experience in a broad variety of analytial testing techniques, including HPLC, UV, CE, Bioassay, PCR, Gel Electropherisis, GC-MS, cell-based potency, and biological assays.
• Experience in statistical analysis of analytical data, including biological assays
• Proficiency in the use of Excel, PowerPoint, Veeva eDMS, and JMP statistcal software.
• Good verbal and written communication skills.
• Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.
• Demonstrated organizational skills to managing multiple projects and priorities.

Education & Relevant Work Experience

• BS Degree in Biology, Chemistry or other Life Sciences
• Minimum of 5 years of related experience
• Experience in Quality setting with particular interest in stability studies and data trending

Physical & Travel Requirements (if Applicable)

• Minimal travel will be required.
• Onsite work at multiple facilities in Massachusetts (Cambridge and Waltham) will be necessary

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The VP of Medical Affairs will be tasked to lead Medical Affairs and Patient Advocacy at Editas Medicines. The individual will be a key partner in establishing and driving forward thinking activities and tactical plans to enable Editas to deliver on its mission to translate the power and potential of genome editing into medicines that transform lives of people living with serious diseases.

The individual will work closely across all internal functions (e.g. commercial, research, development, clinical operations, competitive intelligence, legal) while establishing a network of thought leaders and patient advocates. Goals will include strengthening Editas’ external presence by 1) creating strong and aligned external messaging and communication strategies, 2) establishing and maintaining external networks and relationships to obtain input to validate and inform on research and clinical project goals, 3) identify opportunities for patient engagement and advocacy (particularly in the rare diseases space).

Responsibilities

• Establish networks of therapeutic area thought leaders, will provide feedback, and participate in the research and development strategy across the product life cycle and different indications
• Translate external input, clinical knowledge, competitive information, and patient feedback to inform on company goals, selection of products candidates, and development strategy
• Provide input into developing clinical research protocols
• Develop health outcomes research for long-term data and return on investment
• Engage with patient advocacy groups to encourage early patient input into development strategy, open up opportunities for study awareness, and assist study feasibility and enrollment
• Proactively identify or create outreach or support activities to allow for patient engagement, feedback, or assist access to clinical trials or treatment
• Lead and provide input into external communication to external stakeholders, including development of key company messaging
• Cross functionally align on internal and external messaging, including communications and publication planning
• Assist clinical operations in developing site, investigator, and patient educational materials
• Create internal awareness of company compliance, and structure for external
• engagement
• Provide assessments of product opportunities and threats
• Develop strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcomes
• Collaborate with Commercial, Legal, and Regulatory for development and review of labelling, advertising and promotional materials

Requirements

Knowledge, Skills & Capabilities

• Hands on and independent self-starter capable of wearing multiple hats and a drive to build an organization from the ground up.
• Previous pharmaceuticals industry experience in a Medical Affairs leadership role, including a deep understanding of related regulations and compliance considerations.
• Demonstrated ability to influence across a matrix structure, and to collaborate in a cross-functional environment.
• Able to establish relationships with different groups of internal/external stakeholders to obtain input and buy in to medical/development strategy and clinical study design.
• Provides motivational leadership to the organization and improve its performance through the creation of processes to obtain early expert, patient, and payer input into clinical candidate selection, development strategy, and clinical trial design.
• Strong problem-solver and business acumen.
• Highly organized and proficient in long range planning to support business and clinical needs to support each step of research and development.
• Excellent verbal, written and interpersonal skills and communication skills.

Education & Relevant Work Experience

• A minimum of ten years of experience in the pharmaceutical/biotechnology industry
• MD, MD/PhD, PharmD or PhD
• Experience or high comfort level in supporting clinical programs across multiple therapeutic areas, and bridging late to early development
• Strong understanding of Medical Strategy, Medical Communications, and importance of Patient Advocacy in advancing portfolios focusing on rare disease
• Experience in Hematology and other Rare Disease Drug Development
• Familiarity with gene and/or cell therapy a plus

Physical & Travel Requirements

• Less than 25% travel at this time, but may increase depending upon projects and portfolio

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas is seeking a highly motivated Automation Engineer / Associate Scientist to join our Technology Platform. In this role, you will help develop cellular assays, and lead the development and deployment of lab automation solutions for research, clinical development, and manufacturing applications. You will work with other scientific and project teams to adapt, scaleup, test and standardize key assays and processes in both research and clinical development, having a direct impact on the newest genomic medical advancements.

An ideal candidate should have a strong background in scaling up cellular, biochemical and NGS assays using a wide range of laboratory automation. This includes liquid handling robots, such as the Biomek I7, acoustic liquid transfer, such as the Echo and automated sample storage systems, such as the Hamilton SAM. The candidate will also coordinate instrument repair and yearly maintenance contracts with the facilities team.

The position will report to the Director of Next Generation Sequencing. The individual will be working with cross-functional teams, including the Technology Platform and the Advanced Technologies Group, and will require creativity and flexibility to build durable automated processes to scale up complex biological systems.

You should be able to work effectively in a multi-disciplinary team and have excellent written and verbal communication skills with a capacity for creativity and innovation to achieve company goals.

Key Responsibilities

• Design and build automated workflows based on assay specific needs.
• Scale up high-throughput cell-based and biochemical assays in 96 and 384 well formats by writing automated liquid handling methods and making use of bulk dispensers.
• Drive innovation as a key resource and technology expert. Explore new areas of lab technology with a forward-looking mindset to improve efficiencies and facilitate discovery.
• Collaborate with members of the QA and Clinical Engineering teams to document instrument qualification and process validation
• Author SOPs for automated methods and train colleagues on proper use and execution of these methods.
• Collaborate with members of the Informatics team to build LIMS tools to support assay automation, sample tracking, and data collection in and ELN system.
• Troubleshoot software errors and equipment malfunctions. Manage maintenance and ensure equipment PMs and calibrations are kept up to date.
• Manage automation labware consumable supplies and ensue key consumables are protected from backorder delays.
• Have familiarity with gene editing, cell culture and molecular biology techniques.

Requirements

• B.S. in cell biology, or related field with 4+ years of relevant experience in industry; or
• M.S. in cell or molecular biology with 2+ of relevant experience in industry

Preferred Skills

• Desire to learn new techniques and share expertise with colleagues
• Independently motivated, detail oriented, excellent troubleshooting and problem solver
• Outstanding organizational skills and ability to multi-task in a fast-paced environment
• Excellent oral and written communication skills
• Excellent interpersonal skills and excels in a team environment

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The Senior Director, Clinical Development, reporting to the VP of Clinical Development will be responsible for the oversight and execution of key clinical assets in Editas’ hematology franchise. This individual will lead the design of the clinical research study protocols for all Clinical phases, while working closely with internal partners on core program teams, clinical development teams, and external stakeholders and clinical research organizations. Additionally, the Senior Director will play a key role in leading external communication with KOLs and Patient organizations, and overseeing the clinical publication strategy and execution at Editas.

Key Responsibilities

• Clinical Leadership, Oversight, and Input
• Execution of key clinical assets in hematology franchise
• Lead medical monitor for clinical studies
• Clinical SME on study team
• Ensuring Quality Medical Science
• Design clinical research study protocols for Phase 1 to Phase 4 studies, including rationale, study population, objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, safety monitoring
• Preparing Clinical Program Strategy and Regulatory Documents
• Provide strategic medical input to disease prioritizations, target product profiles, clinical trial protocols, clinical development plans, and regulatory documents and submissions, including INDs/IMPDs, BLAs/MAAs, and expedited pathway applications;
• Maintain clinical knowledge of treatment landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments.
• Participating on Cross-Functional Teams
• Provide medical expertise on program core teams and clinical development teams;
• Work collaboratively with internal teams, consultants, and clinical research organizations to advance programs, management, and external stakeholders
• Leading External Communications
• Interact with external key opinion leaders and patient organizations;
• Moderate advisory board meetings and focus groups;
• Oversight, input, and support across pre-clinical to clinical programs
• Evaluation of assessment measures;
• Interpretation of clinical trial results.
• Oversee clinical publication strategy and execution, including giving presentations at conferences and submitting manuscripts to support company objectives.

Requirements

Knowledge, Skills & Capabilities

• Understanding of the spectrum of drug development, from IND enabling, translational through late-phase development
• Understanding of genetic concepts and molecular biology laboratory techniques; knowledge of gene therapy and orphan disease drug development is beneficial
• Familiarity with pharma/biotech clinical operations, including conduct of research collaborations and relevant regulatory and legal requirements, including ICH, GCP, and HIPAA
• Exceptional leadership capabilities to manage team members and lead a function
• Ability to work cross-functionally to influence others and promote key initiatives
• Experience interacting with clinical investigators and medical experts
• Excellent verbal, written, and interpersonal communication skills; able to clearly communicate concepts and information in writing and via formal presentations to scientific and medical experts internal and external to the company.

Education & Relevant Work Experience

• MD or MD/PhD required with specialty board certification preferred
• Strong clinical and scientific background
• Experience with gene or cell therapy, or hematology preferred
• 3-5 years of pharmaceutical or biotechnology industry experience in clinical drug development; experience designing and running clinical trials and interacting with regulatory authorities.
• Regulatory experience, including interactions with FDA/EMA and submitting INDs/IMPDs and NDAs/BLAs/MAAs

Physical & Travel Requirements

• Business-related travel ~ 10%

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Develop, optimize, and implement biophysical assays to support process development & process characterization to drive late-stage activities towards BLA.
• Design and execute forced degradation, stability, impurity identification and characterization studies.
• Lead the technical transfer of assays to Quality Control or central testing laboratories and provide SME support as needed.
• Compile and present data and assist in authoring and reviewing of test methods, technical reports, and protocols.
• Cross-train personnel on various biophysical assays, as required, and provide guidance to junior research associates.
• Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner.

Requirements

Knowledge, Skills & Capabilities:

• In depth knowledge of assay development for biologics including separation sciences (HPLC/UPLC), isoelectric focusing (icIEF), capillary electrophoresis (CE-SDS) and light scattering methods (MALS/DLS).
• Demonstrated experience with independent method development and complex study design.
• Experience with mass spectrometry (ESI-MS, intact and peptide map) is preferred but not required.
• Experience with technical transfer of GMP test methods for biologics.
• Innovative & collaborative with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals.
• Strong interpersonal, verbal, and written communication skills and knowledge of CRISPR gene editing technology.

Education & Relevant Work Experience

• PhD in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 2+ years of relevant analytical development experience. Bachelors in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 12+ years of relevant analytical development and tech transfer experience or a Masters with 4+ years of experience.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Editas Medicine is seeking a highly motivated in vitro cell biologist at the level of Senior Research Associate or Associate Scientist I to join our Gene Editing Target Discovery group. In this role, you will support on-going efforts to develop gene editing therapies for ocular indications and for exploratory new targets in non-ocular tissues/organs. You will contribute to the development of cell-based assays and ex vivo methods to evaluate the extent and effects of gene editing. An ideal candidate should have a background in primary cell culture and molecular biology, as well as a track record of creative thinking and a strong interest in genome editing. The successful candidate will be part of a dynamic, multidisciplinary discovery team dedicated to the development of gene editing-based therapies for major disease indications.

Key Responsibilities

• Develop and optimize cell-based assays (primary and immortalized cells) to evaluate editing
• Plan, perform, and analyze DNA/RNA extraction, qPCR, and ddPCR
• Develop and optimize protein quantification assays such as Jess automated western blot and ELISA
• Aid in the formulation of lipid nanoparticles
• Establish relevant ex vivo models to determine transfection or transduction and editing
• Analyze and present data within the organization
• Share responsibility in maintaining lab equipment and reagent inventory
• Maintain an electronic lab notebook and contribute to supporting documentation

Requirements

Minimum Requirements:

• BS degree with 2-5 years of experience or MS degree with 1+ years of experience in cell biology or related field
• Experience with mammalian cell culture, including primary cells
• Proficient in molecular biology analyses such as qPCR and ddPCR
• Experience running immunoassays (immunofluorescence, Jess automated western blot and ELISA)
• Results-driven with excellent attention to details and ability to independently execute protocols
• Excellent written and oral communication skills·
• Ability to work in a team-oriented, multidisciplinary environment

Preferred Qualifications

• Experience with formulating and working with lipid nanoparticles
• Experience with dissection and microdissection, isolation of DNA/RNA from tissue

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The Head of IT Infrastructure leadership role requires the successful candidate to be able to engage at a strategic and operational level, with occasional hands-on technology support. The role is a member of the Information Technology Leadership Team (ITLT), reporting to the Head of Information Technology.

The Head of IT Infrastructure provides both the strategic direction and operational management of the organization's technical infrastructure (including hardware, software, servers, databases, storage solutions, networks, and high-performance computing) in support of business needs. They are also tasked with developing long-term plans for how these resources should be used in the future and the strategic direction of technology infrastructure. The objective of this role is to collaborate with stakeholders, users and other IT colleagues to maintain a reliable computing environment, delivering quality processes, controls, and system support to Editas. The Head of IT Infrastructure is also responsible for ensuring the overall planning, execution, and success of projects related to building scalable, fault- tolerant, and redundant systems infrastructures. This requires strong business knowledge, technical knowledge, management skills, and a passion for understanding the current and future state of the company and the IT industry in general.

• Sets the mission, vision, and strategy of the Infrastructure function to maximize the success of business and IT enterprise initiatives.
• Design and implement short- and long-term strategic plans to make certain the IT infrastructure meets current and future needs.
• Overall planning, execution and successful delivery of all infrastructure projects.
• Manage and ensure optimal operation of all IT infrastructure equipment on a 24 x 7 basis.
• Manage and provide direction for the team in support of business operations.
• Ensure high availability, backup, and continuity of all IT infrastructure, continuously monitoring reliability, resiliency, and performance, and developing and executing projects as necessary to maintain IT operations.
• Lead initiatives and necessary upgrades, maintenance, and migrations for IT infrastructure.
• Develops and controls the annual Infrastructure budget to ensure that it's consistent with the overall strategic objectives of IT and the enterprise and is within plan. Drives a culture of continuous cost optimization.
• Develop, implement, and maintain policies, procedures, and associated training plans for IT infrastructure.
• Establish best practices and policies for installing, configuring, maintaining, and troubleshooting.
• Ensure disaster recovery plans are in place for all key infrastructure components. Maintain and test to ensure solutions are effective.
• Continuously evaluates the business value of Infrastructure, including the use of metrics such as Key Performance Indicators, Outcome Driven Metrics and Objectives and Key Results.
• Develop and deploy methodologies for testing infrastructure performance and providing performance statistics and reports.
• Collaborates closely with the Head of Information Security to ensure Infrastructure contributes to, embraces, and applies security strategy.
• Collaborates with Head of End User Services and defines, develops, and manages a comprehensive and integrated IT Service Management (ITSM) landscape, based on best-practice processes, disciplines, and related toolsets.
• Collaborates with the Information Technology Leadership Team (ITLT) on the infrastructure portfolio and governance required to prioritize resources, including budget. Works with key stakeholders to measure and prioritize technical debt remediation.
• Research and make recommendations on products and services.
• Builds successful stakeholder relationships with other IT and business key stakeholders by developing a clear understanding of business needs, acting as a trusted advisor, and ensuring cost-effective delivery of infrastructure services to meet those needs.
• Develops and executes a strategy to improve awareness of the business value that the Infrastructure function provides, and continuously seeks to ensure alignment to stakeholder needs.
• Champions Infrastructure involvement in the organization's innovation efforts and encourages experimentation with innovative solutions to enable business opportunities.
• Participate in audits and assessments of the IT infrastructure

Requirements

Required Skills & Capabilities

• Influencing and negotiation skills where resources required for success may not be in direct control of this role
• Excellent knowledge of current protocols and standards.
• Proven experience with troubleshooting principles, methodologies, and issue resolutions techniques.
• Ability to communicate ideas in both technical and user-friendly language.
• Excellent analytical, mathematical, and creative problem-solving skills.
• Logical and efficient.
• Experience managing cross functional teams.
• Strong customer-service orientation.
• Excellent listening and interpersonal skills.
• Demonstrates technical competence and effectively delivers support in areas of expertise.
• Responsive to internal and external requests; provides high quality service and support.
• Demonstrates ability to work effectively with others and independently.
• Effectively manages projects, meeting necessary deadlines.
• Resolves problems quickly and effectively.
• To the extent permitted by applicable law, eligible candidates must be authorized to work in the United States without sponsorship or restriction, now and in the future.
• Excellence in delivery of hybrid-working to improve user experiences
• Budget planning and financial management
• Applying infrastructure capabilities to achieve regulatory or statutory compliance requirements.
• Third-party management, working closely with sourcing and vendor managers.

Recommended Skills & Capabilities

• Deep understanding of current and emerging infrastructure technologies and practices, and how other enterprises are employing them
• Experience developing strategies to leverage teams that embrace business technologists, e.g. Informatics
• Establishing and improving working practices e.g., ITIL.
• Experience working in a team-oriented, collaborative environment.
• Solid technical knowledge of firewalls.

Specific Experience Required

Vendors: AWS, Azure, Cisco, Microsoft

Technologies: Routing, Switching, Firewalls, collaboration tools, compliance suites, End-point management systems, remote backup technologies, DHCP, Active Directory, Email system administration

Hands-on skills: Required: basic understanding of Operational Change Management practices, working knowledge of Network Routing and Switching, Firewall Policy and ACL, Server and OS administration, leased line connectivity and telecoms vendor management. Recommended but not required: CompTIA Network+, ITIL v3, PMP, AWS- Practitioner, CCNA/CCIE, Azure Administrator, Six Sigma

Education & Relevant Work Experience

• Bachelor’s or master’s degree in computer science, information systems, business administration, related field, or equivalent work experience
• Ten or more years of experience in IT or business/life science
• Three or more years of leadership responsibilities, including strategy, budgeting, and staffing

Physical & Travel Requirements

• Travel to other Editas sites and vendor locations, as required

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

Senior Associate Scientist II (Editas Medicine, Inc.; Cambridge, Massachusetts): The Senior Associate Scientist II translates and analyzes the potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. The individual assists to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. The Senior Associate Scientist II utilizes previous cell culture and molecular biology experience to contribute to our ophthalmology discovery group. This individual is committed to the development of gene editing-based therapies for genetically treatable ocular diseases. Specific duties include: Design and execute assays to evaluate CRISPR/Cas editing; Generate stable cell lines to recapitulate aspects of disease phenotype; Develop and optimize protocols to evaluate viral and non-viral transduction/transfection; Perform molecular biology work, including plasmid design and cloning, DNA/RNA extractions, western blot, and PCR; Train and coordinate lab activities for junior lab members; Analyze and present data within the organization; Share responsibility in maintaining lab equipment and reagent inventory; Maintain an electronic lab notebook and contribute to supporting documentation.

Requirements

Minimum requirements: Bachelor’s degree or foreign equivalent in Biology, Molecular/Cellular Biology, or a related field, plus 8 years of professional, post-degree biotechnology or pharmaceutical research experience.

Must have: Demonstrated experience with AAV and lentivirus vector design and subcloning; Demonstrated experience with CRISPR technology; Demonstrated experience with mammalian cell culture, including primary cells; Demonstrated experience with generating stable cell lines; Demonstrated knowledge of molecular biology techniques (including plasmid cloning, DNA/RNA isolation, PCR, and ddPCR); Demonstrated experience troubleshooting assays, including consulting the literature for potential precedent. (Unless otherwise indicated, the employer is seeking ability in skills listed above with no specific amount of years of experience required. All experience can be gained concurrently).

To apply, send resume to: Victoria Cirillo, HR Manager, Editas Medicine, Inc. 11 Hurley Street, Cambridge, Massachusetts, 02141. Ref: 00033539. An EOE.

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a gene editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Lead growing finance team in all aspects of Editas’ accounting operations, treasury, technical accounting, SEC Reporting, and tax functions, with strong focus on the growth and development of team members.
• Partner across Editas with key business partners to develop and document methodology for review high risk areas such as collaborative revenue and R&D accruals.
• Research and document conclusions related to technical accounting items. Responsibilities include the review of contracts, drafting accounting memos, and ensuring alignment with auditors.
• Contribute to external reporting processes and ensure preparation of SEC filings including Form 10-K, Form 10-Q, and Form 8-K; support Proxy and Financing filings.
• Serve as primary contact for quarterly reviews and annual audit with both internal and external auditors.
• Drive internal process improvements and continually identify opportunities for automation across financial systems.
• Liaison with tax advisors/preparers, including assistance in the tax provision preparation and review of annual federal and state returns.
• Assist with implementing new accounting policies and procedures and keep current on accounting and financial reporting developments, new FASB pronouncements, SEC guidance and disclosure guidelines.
• Oversee all aspects of the company’s equity program, administration, and stock-based compensation accounting.
• Maintain internal control best practices in order to ensure SOX compliance.
• Assist in ensuring that Business Partners within the organization understand the implications of upcoming Finance initiatives or accounting guidance adoption.

Requirements

Knowledge, Skills & Capabilities:

• Strong leadership abilities with emphasis on coaching and developing team members for future growth opportunities.
• Solid communication and interpersonal skills to enable working with stakeholders across various departments at Editas.
• Self-motivated problem solver.
• Able to work well independently and make informed decisions.
• Able to handle multiple projects in a fast paced, deadline driven work environment.
• Proficient in Microsoft Suite (including Excel, and PowerPoint)
• Experience with Oracle Fusion, ADP Workforcenow, Toppan Merrill Bridge, and Equity Edge strongly preferred.

Education & Relevant Work Experience

• 8-10 years in Finance/Accounting (including experience in a public accounting firm); public biotech/pharmaceutical experience a plus
• Bachelor’s Degree in Accounting / Finance; CPA strongly preferred

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities

• Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies
• Provide leadership and input into global subject/patient recruitment plans.
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
• Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
• Participate in Case Report Form design, user acceptance testing in partnership with data management
• Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
• Budgets, timelines, and forecasts preparation for clinical studies.
• Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Regulatory, Medical Affairs, which may include leading sub- teams and/or acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
• Generate country specific Informed Consent Form(s).

Requirements

Knowledge, Skills & Capabilities:

• Strong regulatory knowledge, including Good Clinical Practices (GCPs)
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning, and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities.
• Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
• Apply project management best practices to programs. Experience in novel clinical drug development.
• Experience with protocol, ICF, CRF, CSR development and review.
• Strong organizational skills and ability to deal with competing priorities.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
• U.S. employees must be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC).

Education & Relevant Work Experience

• Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
• 3+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
• 2+ years clinical project management experience with global clinical studies

Physical & Travel Requirements

• Ability to travel (no more than annual average of 20%

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

The Regulatory Affairs Manager, reporting to the Senior Director, Regulatory Affairs, will provide operational support on strategic regulatory deliverables critical to Editas Medicine’s In Vivo and Ex Vivo Gene Therapy programs. This person will partner with the Regulatory Lead in preparation of health authority interactions and play a key role in ensuring operational excellence for our RA strategy & policy. This individual will need to leverage industry expertise in these efforts to ensure operational preparedness for future regulatory filings.

Key Responsibilities & Accountabilities

• Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
• Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
• Provide operational support on strategic regulatory documents to help drive timely deliverables
• Drive operational excellence in Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
• Additional responsibilities, in conjunction with regulatory leads and regulatory CMC lead, include BLA maintenance submissions
• Safety and Annual report submissions (regulatory components)
• Coordinating and drive rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.
• Maintaining global submission plans and supporting those plans can be executed on time
• Coordinating and driving global regulatory sub team meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with sub team members to uphold accountabilities and drive decision-making

Requirements

Knowledge, Skills & Capabilities:

• Ability to rapidly adapt to different issues and projects at one time. Expert in planning and delivering work on time keeping quality parameter in mind;
• Knowledge of regulatory procedures in appropriate region
• Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
• Ability to recognize, articulate, and accept calculated risks to make informed decisions
• Develop understanding of different TAs due to assignment to different projects.
• Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
• Increased exposure to global and multi-functional teams.
• Good working knowledge of regional regulatory intelligence;
• Ability to work closely with client regional heads to determine the Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, publishing projects
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
• Proficient with relevant submission software, including but not limited to, Veeva, Adobe Acrobat, Microsoft Office, eCTD viewers.

Education & Relevant Work Experience

• Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine).
• Bachelor’s degree in related discipline and a minimum of 5 years of related experience; or
• Master’s degree in related discipline and a minimum of 3+ years of related experience; or
• PhD degree in related discipline and a minimum of 2 years of related experience; or Equivalent combination of education and experience
• Demonstrates a high-level of self-motivation and professional commitment.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.