Longevity Industry Jobs

The Clinical Trial Manager must fully understand and lead the cross-functional team through all day-to-day activities within the clinical trial life cycle. These day to day activities include managing all trial start-up, conduct and close-out activities to both industry and corporate standards within ICH/GCP Guidelines.

Responsibilities:

• Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities.
• Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals.
• Contribute to development of template Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO partnerManage the day to day operational management activities of CROs and study vendors.
• Contribute to (or oversee the management of) the creation of the trial plans and site facing documents.
• Developing (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members.
• Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
• Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
• Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate.
• Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study.
• Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial.

Qualifications:

• (CTM) Bachelor’s Degree in a related field with three to five years’ experience in the biotech and/or pharmaceutical industries managing clinical trials.
• Phase I experience is preferred, particularly in Oncology or Rare Disease development.
• Thorough understanding of GCP/ICH Guidelines, as well as strong understanding of cross-functional clinical processes.
• 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.
• Ability and willingness to travel up to 20% (domestic and international).

Beam is expanding our geographical footprint to RTP, NC with the recent announcement of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA. We are looking for highly energetic Manufacturing Associates to support start-up and scaling of cGMP manufacturing at our new RTP site. Reporting to the Manager of Manufacturing, the successful candidates will provide manufacturing, operational & technical experience around commissioning, training, qualification, and start-up. The ideal candidates will have experience in cell or gene therapy, along with demonstrated ability in a GMP environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships in a team environment.

Key Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on people.
• Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing.
• Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations.
• Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
• Champion development of a learning culture that embraces innovation and continuous improvement.
• Support establishment of long range and business continuity plans.
• Support up to but not limited to multiple areas of GMP production as needed.
• Represent department during audits and regulatory inspections.
• Establish and maintain strong relationships at the site and cross-functionally.
• Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines.
• Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
• Support facility and equipment qualification and training for the ability of meeting process and regulatory expectations.
• Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
• Assist MFG support functions in relation to manufacturing deviation investigations and change controls / CAPAs.

• Must be able to work onsite.

Required Experience & Qualifications:

• BS, MS a plus, in Life Sciences or Engineering with minimum of 0-5 years of relevant experience.
• Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
• Proven experience as a contributor in a cGMP manufacturing operation; experience leading cell/gene therapy manufacturing operations strongly preferred.
• Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
• Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
• Demonstrated business acumen.
• Dynamic interpersonal skills and the ability to manage through influence.
• Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership, and drive.
• Experience supporting and assisting event investigations, Root Cause Analysis (RCA), and CAPA.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.

Beam is seeking a highly motivated and talented financial specialist to join our growing Accounts Payable team. The Sr. Accounts Payable Associate will have a day-to-day and ongoing impact on financial transactions and keeping us on good terms with our valued partners and suppliers. This includes ensuring accurate and timely processing of invoices while collaborating with team members to reconcile processed data.

Responsibilities:

• Performs day to day financial transactions, including verifying, classifying, and recording accounts payable data.
• Provide efficient client service to team members and related third parties.
• Review all invoices for appropriate documentation and approval prior to posting.
• Verify and investigate discrepancies, if any, by reconciling vendor accounts and monthly statements in compliance with financial policies and accounting procedures.
• Keep track, process, and reconcile payments, including invoices, statements in compliance with financial policies and accounting procedures.
• Assist with quarterly audits
• Assist with month end close and ad hoc projects as needed.

Qualifications:

• Minimum 4+ years of accounts payable work experience in Biotech
• General knowledge of accepted accounting principles
• Proficient in Excel and MS Office skills strongly preferred
• Excellent written and oral communication skills
• High degree of accuracy, attention to detail, and organizational skills
• Ability to work independently and prioritize work tasks for month/quarter end cycles
• Experience with accounting software and database programs including NetSuite & Coupa strongly preferred
• Able to maintain confidential and sensitive information.

The Senior Study Manager will manage the outsourcing operations for Nonclinical Development studies to CRO sites enabling the transition of a R&D project from entry into development up to and beyond NDA/BLA submission. Outsourcing management includes business relevant processes from the CRO sourcing to study reporting like requesting quotes, launching purchase orders, engaging with procurement and legal as required. In close collaboration with Beam team members and internal stakeholders, the Nonclinical Development Senior Study Manager oversees the initiation, progression, and quality of operations at the vendor under adherence to scientific project team objectives, strategy, and timelines.

Responsibilities:

• Point of contact for study communications, activities, and documents from pre-study to study closure (finalization and archiving).
• Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan.
• Support vendor quality oversight in partnership with Nonclinical leadership, Nonclinical Development Operations and Quality Operations.
• Manage, communicate, and ensure adhesion to study timelines and milestones
• In partnership with the Beam scientists, contribute to the study design, and regulatory submissions (as applicable).
• Work collaboratively with internal and external cross-functional teams or stakeholders.
• Preparation, review, and finalization of nonclinical study documents including protocols, amendments and reports.
• Participate in CRO vendor selection/ due diligence activities.
• Assist in supplier cost and performance at the study level with attention toward opportunities for cost efficiencies.
• Responsible for working with CROs to request slot availability and request quotes for the planned nonclinical studies.
• Communicate and manage study changes and issues; know when and how to escalate issues to management for resolution.
• Monitor the performance of nonclinical studies onsite or remotely at Contract Research Organizations.
• Maintain collaborative relationships and communications between external service providers.
• Ensure compliance with study protocols, GLP regulations (as applicable), and department work instructions.
• Coordinate study samples receiving and archiving

Qualifications:

• Bachelor’s degree in a scientific-related field with a minimum 10 years of experience in the pharmaceutical, biotechnology, CRO industry.
• Familiarity and working knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology).
• Familiarity with GLP regulations for the conduct of nonclinical studies to support regulatory filings.
• Demonstrated a team player attitude, ability to work independently in a fast paced, dynamic, and changing environment, takes initiative to identify, analyze and resolve issues.
• Ability to travel to CRO to monitor outsourced studies.
• Experience in working with CROs.
• Excellent communication and presentation skills.

Beam is seeking a Software Engineer to design and implement software supporting our research and laboratory automation initiatives. The individual in this position will contribute to full stack software solutions bridging cloud-based LIMS systems, internal databases, and physical hardware. This position will work closely with the Laboratory Automation team to align the solutions with the requirements of the laboratory instrumentation while ensuring usability, consistency, and maintainability.

Primary Responsibilities:

• Write code and scripts that support research initiatives, for example, by processing raw assay data, recording sample information/results in databases, providing webpage UIs for common data entry, etc.
• Develop and maintain software for use in regulated environments, including GxP compliant lab testing.
• Collaborate with the Laboratory Automation team to plan and develop software integrations between virtual and physical systems.
• Work as part of the High-Throughput Computational Sciences team to develop data connections and data infrastructure for downstream software, analytics, and machine learning.
• Gather requirements and execute software implementation.
• Fluidly design and deploy cloud-based software tools, APIs, webservers, UIs, and serverless infrastructure.
• Actively communicate with stakeholders to understand their workflows and computational needs.

Qualifications:

• Bachelor’s degree in computer science, bioinformatics, or related field, or equivalent experience.
• 1+ years of biotech industry experience preferred.
• Demonstrated interest in biotech, with previous biotech work experience preferred.
• Programming expertise in Python, Java, and/or SQL.
• Previous web development preferred.
• Hands-on experience with Benchling and AWS services including Lambda, ECS, ECR, EC2, RDS, DynamoDB, APIGateway, EventBridge, and AWS-CDK is preferred.
• Demonstrated ability to work both independently and as part of a team of software engineers.

Beam is seeking a highly motivated Scientist with experience in oligonucleotides downstream production who is passionate about enabling the translation of cutting-edge research technologies into therapeutic applications. The successful candidate will assist in process development of novel approaches to synthesize and manufacture synthetic RNA for CRISPR/Cas gene editing. The ideal candidate for this role is detail-oriented, persistent, and has an innovative mindset toward solving technical challenges.

Primary Responsibilities:

• Develop and evaluate processes for the synthesis, purification, and analysis of synthetic RNAs.
• Evaluate new approaches and provide technical guidance on optimal downstream conditions to produce synthetic RNAs.
• Establish chromatographic processes to purify RNA to be used in R&D and pre-clinical manufacturing.
• Interface with Analytical Sciences, Process Development, Delivery, Pharmacology, Platform and Disease program teams.
• Author, review, and approve protocols, SOPs, technical documents, and reports for RNA chemistry lab.
• Independently plan and execute experiments, perform data analysis and interpretation.
• Deliver reproducible and impactful results in a fast-paced environment.
• Understand the landscape of clinical and process materials, liaise with vendors, and maintain appropriate inventory.
• Maintain thorough electronic lab notebooks and documentation records, and present findings to multi-disciplinary teams in various oral and written formats.
• Adhere to all laboratory safety requirements and procedures, assist in maintaining general laboratory functionality, including lab equipment maintenance and the ordering, and receiving of lab supplies.

Qualifications:

• Ph.D. Degree in Chemistry, Biochemistry, Chemical Engineering, or related fields with 0-2 years of relevant industry experience, or M.S. in Chemistry, Biochemistry, Chemical Engineering, or related fields with 8+ years industry experience.
• Experience purifying (anion exchange, reversed phase, size exclusion chromatography and TFF) oligonucleotides.
• Experience purifying biomolecules on an AKTA chrom system is a plus.
• Experience and/or working understanding of common techniques used to analyze oligonucleotides, such as HPLC/UPLC, UV/Fluor, CD and LC-MS.
• Strong knowledge of nucleic acid chemistry, nucleic acid structure-activity relationships and safety profiles is desirable.
• Excellent communication skills and the ability to present effectively to others with diverse scientific backgrounds.
• Desire to embrace challenges of developing novel technologies and work flexibly in a fast-paced, team-oriented environment.r

We seek a highly skilled and innovative scientist to join Beam’s platform technology development group. This position is focused on structural biology that supports the development and engineering of novel gene editing proteins. The candidate should have a deep understanding and experience in cryo-electron microscopy and X-ray crystallography methods and broad knowledge of protein biochemistry and biophysics.

Primary Responsibilities:

• Independently design and execute cryo-EM and/or X-ray crystallography projects to study the mechanism of action for novel gene editing enzymes and other therapeutically relevant proteins
• Prepare cryo-EM grids, collect data, and determine the structures for the protein-protein or protein-DNA/RNA complexes of interest. Earlier stage work, including molecular cloning and protein production, will be carried out by other scientists, but the candidate may remain involved if a project-specific need arises
• Protein crystallization and structure determination of the proteins and protein-DNA/RNA complexes of interest.
• Lead or contribute to protein engineering and construct optimization by providing structural biology insights
• Closely collaborate with other platform scientists to drive the timely hypothesis-to-test cycle for the discovery and optimization of novel gene editing enzymes
• Communicate scientifically rigorous structural biology findings via verbal and written communications, visualizations, and presentations, mainly to non-structural biologists
• Maintain clear and accurate records of experimental methods and results

Qualifications:

• A Ph.D. in Structural Biology, Biochemistry, Biophysics, or equivalent, with expertise in cryo-EM or X-ray crystallography
• Extensive knowledge in Structural biology, protein biochemistry, and protein engineering.
• Aptitude with detailed structural analyses and integration of structural observations into subsequent construct engineering and optimization
• Computational modeling experience is not a must but will be a significant plus
• Experience with gene editing proteins (e.g., CRISPR/Cas9) will be a significant advantage
• Demonstrated ability to work independently in a fast-paced and dynamic environment
• Ability to adapt to increasing scope and complexity of work brought on by growth/change

The Quality Control Analyst will support critical analytical method implementation workstreams in support of GMP testing laboratory start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Cambridge, Massachusetts.

Primary Responsibilities:

• Maintain QC laboratory including instrument calibration, PMs, and operational SOPs.
• Perform Release Testing, Qualification, Validation and Method Transfer for various cell therapy methods.
• Perform stability testing, assist, keep records of stability sample pulls, and write/revise stability protocols.
• Support the implementation and execution of training programs within CoE.
• Work independently and assist Sr. Analysts for sample and stability analyses.
• Responsible for daily and weekly lab chores.
• Collaborate with multiple departments for on-time completion of variety of analyses.
• Participate in process improvement for a faster turnaround time, OTIF (on-time in full) completion of projects.
• Prepare the data packet for review and peer-review the data.
• Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors.
• Support stability data analysis along with stability document reviews.
• Tracking and ordering of laboratory reagents and materials.
• Sample receiving per the BEAM-SOP guideline.
• General cleaning and upkeep of the laboratory and equipment.
• Escalate complex issues to QC Manager and SMEs in the lab.

Technical Skills:

• Prior lab-experience is needed.
• GMP experience as a QC personnel is desired.
• Technical least one of the following analyses: mRNA, LNP, CFU, Potency assay, gRNA, NGS assay, Flow Cytometry, PCR, ELISA, and/or Multiplex.
• Hands-on experience is preferred (but not mandatory) with HPLC (DAD-CAD, UV-ViS), UHPLC, and/or Mass-Specs.
• Analyze data; interpretation of data within given parameters.
• Prior knowledge of LIMS, VEEVA, and/or KNEAT preferred.

Qualifications:

• Bachelor’s degree required, preferably in a chemistry, life science, or related discipline.
• 0-3 years relevant experience.
• Prior GMP experience is desired.
• Scientific knowledge and direct experience with analytical method transfer processes.
• Advanced technical writing skills.
• Advanced problem-solving ability.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Collaborative with “Team First” mentality.
• Communicate effectively with peers, and demonstrate collaboration across different functional groups.

We are searching for a dynamic Buyer to join procurement. The Junior/Buyer will be a key member in transforming Procurement function reporting directly to the head of procurement and strategic sourcing. The selected individual will have exposure across all Beam categories and spend. The role will focus on, Coupa system oversite, system integration, and routine system review.

The ideal candidate will manage and execute buying decisions in order to ensure uninterrupted product flow. To coordinate product availability information externally and internally to ensure that all deliverable dates are met in order to reach facility service-level goals

Responsibilities:

• Reviews orders for completeness, accuracy, and compliance with existing policies and procedures.
• Facilitate, onboard, and maintain P2P system users, including new user training.
• Performs day-to-day tasks. Set up system notifications, review of aged purchase orders and responsible for resolving discrepancies.
• Own Procurement mailbox. Answer any questions, follow up with supplier and internal sponsors as needed.
• Ensure that all purchase orders between the department and selected vendors are compliant with all institutional and departmental policies.
• Supports and manages the setup, data input, and maintenance of online catalogs and supplier enablement.
• Facilitate Beam’s purchasing policy. Ensure the policy is reflective and facilitates the needs of the business.
• Work with suppliers as needed to resolve inconsistencies, ensure accurate and on-time delivery.
• Collaborate with Accounts Payable on purchasing discrepancies and other issues.
• Seek innovative solutions for the purchasing process and participate in cross-functional teams.
• Opportunity data analysis & reporting for vendor spend and consolidation.
• Ad hoc projects and process improvements.

Qualifications:

• 1+ years’ experience in a Procurement/Sourcing or Supply Chain Environment.
• Bachelor’s degree in Finance, Accounting, Economics, Business or a related field.
• Coupa systems or Procurement system knowledge.
• Strong process-mapping and process-improvement skills with close attention to detail.
• High degree of customer focus and demonstrated collaboration in a team environment.
• Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Strong Microsoft Office suite skills.

Beam is seeking a motivated and collaborative individual to join our Protein Sciences group responsible for supporting method development, purification, and characterization of our novel base editors and other proteins of interest. The successful applicant will have experience in molecular biology, protein expression systems (bacterial/mammalian/yeast), and protein chromatography. Candidates should be highly self-motivated with an analytical mindset with the ability to excel in a fast-moving and goal-oriented environment.

Responsibilities:

• Contribute to the scientific strategy, discussion, and output of the team.
• Perform and evaluate studies to improve yield and purity of purified targets.
• Perform protein expression and purification of novel base editors and proteins of interest.
• Assist in method development campaigns to assess robustness of purification strategies.
• Assist in the design and implementation of activity and release criteria assays of purified base editors/target proteins.
• Assess scientific literature and properly apply it to increase knowledge base.
• Document, present, and communicate scientific findings.

Qualifications:

• BS in Chemistry, Biochemistry, Chemical Biology, Molecular Biology, Biotechnology, Chemical Engineering or equivalent and a minimum of 1 year (RA) to 4 years (Sr. RA) of experience in protein biochemistry.
• Familiarity operating AKTA FPLC instruments.
• Theoretical and practical knowledge on purification sciences with an emphasis on strategies applied to the purification of biological macromolecules.
• Proficient in molecular biology applications including primer design cloning, DNA purification and quantification methods.
• Candidate must be familiar running various protein characterization assays (SDS-PAGE, UV-VIS spectroscopy).
• Self-driven, analytical, and detail-oriented scientist with a strong problem-solving mindset and a strong curiosity towards areas of protein science previously unknown to you.
• Excellent written and verbal communication skills with the ability to present effectively to teams with diverse scientific backgrounds.
• Familiarity with the use of ELNs and inventory management.
• Familiarity with DoE approaches for the improvement of purification processes.
• Familiarity with plasmid mechanics (g. selection of RBS strength, promoter strength, protein induction strategies).
• Familiar with the use of programs like MS Excel, MS PowerPoint, GraphPad Prism, Geneious, and JMP.

The Analytical Lead will design, plan, oversee and coordinate analytical activities for our Hematology cell therapy platform as well as future delivery platforms. This role will focus on CMC related analytical activities beginning at pre-clinical and preceding through commercial launch. This role will oversee internal and external activities including, but not limited to, method development, method transfer, phase appropriate method qualification/validation, non-GMP testing, non-GMP stability, reference standard qualification, and comparability. Candidate should have expertise in various techniques, such as flow cytometry, NGS, qPCR, ddPCR, DNA and RNA extraction, ELISA, western blotting, transfections, electroporation, and cell-based potency.

Primary Responsibilities:

• Establish Analytical CMC Strategy for Hematology cell therapy programs.
• Work on cross-functional CMC team progressing candidates from pre-clinical through commercial launch.
• Authors and coordinates writing of test methods and ensure timely transfer of test methods to CDMOs, CTOs, and Quality.
• Coordinates writing of and authoring of method qualification reports and reference standard qualification protocols and reports.
• Define analytical control strategy for Hematology cell therapy programs.
• Establish product characterization studies.
• Creation of justification of specifications and specifications documents.
• Authors all relevant sections of IND and BLAs as well as respond to regulatory agency questions.
• Interface with CMC, Quality, Regulatory, Manufacturing, Process Development, and Beam partners.

Qualifications:

• Degree (MS, PhD) in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields).
• Minimum 15 years (MS) or 10 years (PhD) industry experience (including biotech, biopharma, CRO, CDMO) including hands on experience in cell and gene therapy.
• Analytical development expertise in protein biotherapeutics, RNA/Oligos, and/or cell therapy products.
• Knowledge and experience in CMC and regulatory strategy, cGMP, ICH guidelines, USP and EP compendial methods applied to cell and gene therapy is preferred.
• Candidate should have expertise in various techniques, such as flow cytometry, NGS, qPCR, ddPCR, DNA and RNA extraction, ELISA, western blotting, transfections, electroporation, and cell-based potency.
• Extensive scientific writing experience, experience authoring IND and related documentation.
• Strong leadership, self-starter and excellent oral and written communication skills.

Beam is seeking a highly motivated Associate Director/Director, Data Management to lead clinical data management activities in support of Beam’s clinical trials. The ideal candidate will work closely with the Beam study team and CRO data management to ensure timely, accurate, complete, high quality data capture. This position will require hands-on work on clinical studies as the first in-house data manager.

Primary Responsibilities:

• Work closely within biometrics function and clinical development to oversee all data management (DM) tasks and timelines.
• Serve as primary DM contact and act as liaison with CROs and third-party data vendors.
• Lead data management study start-up and maintenance activities including CRF design, cross functional CRF review, database building, edit check specifications, user acceptance testing, SAE reconciliation, review of CRF completion guidelines, CRO data management plans, external data transfer specifications and other essential documentations.
• Provide expertise regarding CDASH and CDISC data standards and collaborate with Statistical Programming to oversee SDTM validation, review of validation report, SDTM Reviewer Guides and define.xml files.
• Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, etc. that are generated for interim analyses, publications, CSRs, DSURs, IBs, and other business needs.
• Support internal data reviews/QC of clinical data and coordinates and ensure successful electronic data transfers.
• Oversight of database lock activities and ultimate archiving of study data.
• Support GCP inspection readiness activities and serve as a primary point of contact for data management during inspections.

Qualifications:

• Requires a Bachelor or master’s degree in a scientific or health-related field.
• At least 10 years of experience in clinical data management within a pharmaceutical/ CRO, with experience in managing Phase I, II and III studies, from start-up through closure for multiple clinical studies.
• Experience with EDC databases including Oracle Inform and/or Medidata Rave, CDASH/CDISC standards, GCP/ICH requirements, and corresponding FDA regulations.
• Experience working with central and specialty labs/vendors.
• Experience developing reports using J-Review and/or other CDM reporting tools.
• Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable.
• Must be well organized, detail oriented with strong analytical and problem-solving skills.
• Must be able to dig in and check the cleanliness of the data including query resolution, data consistence and data cross checks etc.
• Experience and knowledge of gene/cell therapy and/or rare disease are desirable.
• Must be self-motivated, and able to work independently and effectively with colleagues and vendors and demonstrate excellent verbal and written communication skills.
• Ability to prioritize and manage timelines and shifting priorities within a fast-paced company environment.

Unique opportunity to join a growing Pharmacovigilance team. This PV expert will be an individual contributor to start with the opportunity to grow his/her team over time. Responsibilities include providing strategic and operational PV support for several Beam products in the pre-market space.

Responsibilities:

• Oversight of day to day safety monitoring activities and safety operations of clinical trials for the assigned product.
• Provide PV subject matter expertise on Clinical Development Teams and other cross-functional platforms throughout the company.
• Facilitate internal cross-functional Safety Management Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda.
• Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents.
• Project lead for DSURs and subject matter contributor to other aggregate documents such as Investigator Brochure.
• Oversight of vendor specific to PV deliverables.

Qualifications:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV.
• 10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV.
• Knowledge of MedDRA terminology and its application.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data.
• Experience in the preparation and authoring of pre- and post- aggregate safety reports.
• Thorough understanding of the drug development process and context applicable to safety surveillance activities.
• Ability to execute and follow-through to completion and documentation.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Independently motivated, detail oriented and good problem solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communication skills and ability to influence across multiple functions.
• Be ready to embrace the principles of Beam.

The Director is accountable for the oversight and execution of Clinical Operations for a full development program within Immuno-Oncology/Rare Disease, and their direct reports on the Immuno-Oncology/Rare Disease Operations team. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management, communication to upper management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines, and are the co-author of the individual study timelines/deliverables/milestones.

Responsibilities:

• Have the skillset and experience to manage (or oversee the execution of – and assisting when necessary) all related study start up, maintenance and close out activities.
• Create and maintain Operations Budget forecast and execution, contribute to the Clinical Development Plan, with program oversight of all aspects of the clinical operations budgets of all studies within their program.
• Responsible for the clinical operations program related timelines and study timelines/deliverables/milestones.
• Have experience with and the ability to prioritize day to day issues and overarching goals with a keen eye to (understanding of and compliance with) ICH/GCP Guidelines, escalating to Upper Management as appropriate.
• Drive RFP generation, vendor selection, review of SOWs and Change Orders, as well as acting as a point of escalation for vendors within their clinical program.
• Contribute to and assist in maintaining a quality-focused clinical infrastructure by assisting in development, revision and/or implementation of SOPs consistent with the organization’s day to day execution of trials such that operational processes, systems and standards are consistent with GXP and are adopted, implemented and documented consistently across trials and programs.
• Develop and maintain strong relationships with cross-functional key stake holders within Beam.
• Strong collaboration with other departments, towards common and related goals.
• Maintain direct reports, regular meetings and oversight as well as complete all yearly review activities; Review and sign off on direct report’s documents.
• Train and mentor direct reports and junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities.
• Lead process improvement initiatives, helping to maintain best practices and lessons learned across programs.

Qualifications:

• Advanced degree preferred, or at least a Bachelor’s Degree in a science based field.
• 10+ years’ experience in the biotech and/or pharmaceutical industries, with at least nine years in clinical operations.
• Global clinical trial/Program Management and Phase I experience are both necessary, as is extensive experience in Immuno-Oncology/Rare Disease development.
• Thorough understanding of GCP/ICH Guidelines, global regulatory requirements and strategic implications for downstream clinical development.
• Extensive vendor oversight and management experience, including negotiations and contract execution.
• Excellent interpersonal and communications skills (verbal and written), including clinical authoring experience of protocols, ICF, IBs, etc., as well as superior problem solving skills.
• Demonstration of strong management abilities and mentoring skills, with preferably six or more years prior experience managing, mentoring and training Clinical Operations staff.
• Ability and willingness to travel up to 20% (domestic and international).

Beam is seeking an enthusiastic, highly motivated, and detail-oriented SRA to work within its Clinical Bioanalytics and translation Science function. The candidate will contribute towards critical reagents and assay development efforts in support of BEAM’s clinical pipeline. We are looking for a scientifically curious team player who is technically competent and can thrive in a fast-paced environment.

Responsibilities:

• Develop in-vitro and in-vivo assays using biochemical, immunological, molecular and cell biological procedures and technologies including qPCR, ddPCR, isolation, culturing, and characterization of immune cells by multicolor flow cytometry, proliferation, apoptosis, cytotoxicity, ELISA, MSD, AlphaLISA, Western blot, IF/IHC, imaging and similar approaches.
• Develop, optimize, and characterize high-quality (GLP/GCLP-grade) assays and maintain associated documentation (such as method protocols) for technology transfer to external collaborators/CROs.
• Generate, analyze, and interpret experimental data and present to key stakeholders.
• Maintain laboratory equipment, facilities, consumables, and materials.
• Maintain clear and complete electronic records of study material and experimental results.
• Work cross-functionally with different internal and external stakeholder groups.

Minimum Qualifications:

• Biological science BS with 4+ years or biological science MS with 2+ years of working experience in drug discovery/development in a biotechnology or biopharmaceutical company.
• Experience in clinical assay development.
• Prior experience with general immunological and cellular and molecular biology techniques (such as cell culture, tissue culture, flow cytometry-based assays, immunohistochemistry, ELISA/MSD/AlphaLISA, and PCR/qPCR/ddPCR).
• Experience in developing assays following regulatory guidance is a plus.
• Excellent organizational skills and oral and written communication skills.
• Ability to think strategically, manage time and workflow, and work independently as well as part of a results-oriented research team.
• Proficiency in use of general bioinformatic and data analysis/visualization tools such as FlowJo, Microsoft Excel, Benchling, GraphPad Prism etc.

Beam is expanding our geographical footprint to RTP, NC with the recent announcement of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA. We are looking for a highly energetic Director of Manufacturing Sciences & Technology to support start-up and scaling of cGMP manufacturing at our new RTP site. Reporting to the Plant Manager Site Head, cGMP Manufacturing, and in partnership with Process Development, the successful candidate will be the single point of accountability for all aspects of the manufacturing process at the site, while providing operational & technical leadership throughout start-up. The Director of Manufacturing Sciences & Technology will develop systems and lead internal tech transfers, provide technical support and subject matter expertise for process equipment to execute cGMP clinical manufacturing, and prepare the site for process validation for commercial manufacturing. This leader will hire and develop staff to support site operational readiness and provide technical support to manufacturing. As a key member of the North Carolina Site Leadership Team, the individual will develop operational strategies to build a nimble, flexible, efficient operation and ensure safe and reliable supply of products. This individual will establish comprehensive plans, procedures, systems, and budgets that are consistent with company objectives. The ideal candidate will be a seasoned leader with a demonstrated track record of building high performing teams. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships, including Process Development partners located in Cambridge, MA.

Responsibilities:

• Cultivate Beam’s culture and our values-driven organization focused on people.
• Define and implement the mission, vision, and strategy for the Beam NC Site Manufacturing Sciences & Technology team.
• Ensure safety, compliance, efficiency, and sustainability throughout tech transfer and cGMP operations.
• Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
• Champion development of a learning culture that embraces innovation and continuous improvement, with a focus on driving process improvements in manufacturing.
• Prepare and maintain departmental budget and workforce model.
• Develop and implement systems for process oversight to monitor operational health, inform strategic decisions, and present materials at management reviews.
• Build a collaborative and empowered team that put patients first.
• Recruit, retain, and develop a high-performing and diverse team.
• Represent department during audits and regulatory inspections.
• Establish and maintain strong relationships at the site and cross-functionally.
• Develops and maintains detailed tech transfer project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
• Support facility and equipment design and qualification for ability to meet process and regulatory expectations.
• Owns and contributes to development and implementation of tech transfer and manufacturing documents (batch records, procedures, and technical reports).
• Lead and/or assist with manufacturing deviation investigations and change controls.
• Manages tech transfer and process scale-up in partnership with PD and Manufacturing.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.
• This is an on-site role. Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.

Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 5 years of relevant work experience, or a Master’s degree with a minimum of 10 years of relevant work experience, or a Bachelor of Science degree in Engineering or Life Sciences with a minimum 15 years of relevant work experience.
• Proven experience as a direct manager of people and as a leader in a Manufacturing Sciences & Technology; experience leading cell/gene therapy manufacturing operations preferred.
• Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
• Strong background in drug development and regulatory requirements.
• Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
• Demonstrated business acumen, including long range planning and budget management.
• Dynamic interpersonal skills and the ability to manage through influence.
• Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership and drive.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.

We are searching for a dynamic Associate Director to join the procurement team. The primary focus of this role will be to establish a Category Management and Strategic Sourcing program for clinical services, actively support the development of a global network of preferred suppliers, and negotiate contractual agreements. This individual will make recommendations to leadership from a stakeholder standpoint, and will leverage experience to improve areas of company-wide procurement, including quality, speed, cost, risk, and ease of use for the business. The Associate director will be a key member in transforming the strategic sourcing function at Beam, and will report directly to the global head of procurement.

The ideal candidate will have a demonstrated track record of working in a dynamic environment, and possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships.

Responsibilities:

• Develop and implement Category Management strategies for Clinical Research, Clinical Support Services, Bioanalytical Development, Regulatory and Compliance.
• Build strong relationships with key suppliers. Leverage segmenting suppliers, and implement a structured supplier relationship management program.
• Support stakeholders by identifying risks as part of the Strategic Sourcing process. Coordinate and develop risk mitigation plans that support business growth.
• Sustain annual cost savings targets, while collaborating with stakeholders and finance department.
• Successfully manage RFx source to settle lifecycle. Identify stakeholder requirements, draft RFx documents, facilitate meetings, vendor sessions, and quartley business reviews with key partners.
• Negotiate supply agreement contracts and pricing terms. Partner with legal to support Beam’s internal controls.
• Leverage market research to obtain benchmarking data. Support category management and use data to drive initiatives for the team.
• Develop an annual category business plan to assess category, set goals and objectives, analyze spend, and review plan with key stakeholders for alignment.
• Partner with quality department to ensure that all activities and documentation comply with regulatory requirements.
• Strong focus on cost savings activities, including cost reduction, cost avoidance, and finding value-beyond savings for business owners.
• Ensure accurate reporting of Procurement key performance measures (operational metrics, savings, etc.).
• Work collaboratively with the purchasing team and leadership to develop and maintain department policies and procedures.
• Partner with senior stakeholders to build relationships that facilitate realization of business value and savings.
• Participate in ad-hoc category projects and process improvements as needed.

Qualifications:

• 7-10 years' experience in a Procurement, Strategic Sourcing or Category Management.
• Skilled in category management and (experience supporting clinical category preferred).
• Strong experience with negotiation of contract agreements, process and cost improvements.
• Strong process-mapping and process-improvement skills with close attention to detail.
• Ability to define, drive, and translate technical specifications from business functional requirements.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Bachelor’s degree in Finance, Accounting, Economics, Business or a related field; Master’s degree preferred.
• Biotech industry experience strongly preferred.
• Strong Microsoft Office suite skills.

The Beam facility in Research Triangle Park is looking for an experienced pharmaceutical maintenance professional to fill the role of Facility Maintenance Technician with depth in servicing HVAC and associated site utility systems. This position supports start-up, manufacturing, site services tasks, coordination of maintenance and site services vendors, and the execution and support of the preventive maintenance and reliability program. In addition to a strong HVAC maintenance and mechanical background and service-oriented mindset, the ideal candidate should also possess the ability to schedule and collaborate with site leadership, vendors, manufacturing operators, quality, and validation.

Responsibilities:

• Respond to and troubleshoot issues with HVAC, plant utilities, and associated equipment during business hours and in on-call rotation.
• Assist with response to issues with calibrated HVAC and utility system instruments for pressure, flow, temperature, etc.
• Respond to alarms from the Building Automation and Process Control systems.
• Create individual work and review vendor work within the site CMMS system.
• Execute daily rounds and maintenance and reliability activities for plant utilities and systems (including but not limited to HVAC, Chilled/Heating Hot Water, Compressed Air, etc.).
• Review and assists with updates for Standard Operating Procedures for site and facility maintenance.
• Review the spare parts inventory program related to site utilities including mechanical and HVAC equipment.
• Ensure compliant operations in accordance with site cGMP, environmental, and federal / state requirements.

Qualifications:

• BS, Associate’s degree, or equivalent experience in a technical discipline related to construction, utilities, or trades.
• 8-10 years’ experience in maintenance within a biotech, pharma, or medical device manufacturing environment.
• Specialized license/certifications in HVAC required.
• In depth knowledge of clean room system air balancing.
• Computer literacy with experience in CMMS (Blue Mountain RAM, Maximo, SAP, or other) Computerized Maintenance Management System.
• Strong background in cGMP manufacturing / operations knowledge, Siemens BAS and DeltaV experience preferred.
• Ability to manage competing priorities and timelines and adapt quickly to changing circumstances.
• High degree of customer service focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, humility, ownership, and drive.

We are seeking a motivated Scientist to join our Analytical Research and Development team and lead method development and qualification for lot release and characterization of cell and gene therapy products and critical materials. S/he will work with a Beam’s Analytical Development team to enable the rapid advancement of cell and gene therapy candidates from pre-clinical development through commercialization. The ideal candidate will be independent and detail oriented, have experience in design and development of novel functional cell-based and molecular assays, work collaboratively with cross-functional teams, and have a working knowledge of analytical guidelines and methods.

Primary Responsibilities:

• Lead development, optimization, and qualification of cell and molecular assays used for lot release and characterization of cell and gene therapy products and critical materials.
• Independently design and perform cell-based and molecular assays including potency assays.
• Identify assay improvement opportunities, and design and execute comparability studies to support assay improvements and process improvements over the lifecycle of the product.
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
• Contribute to technical transfer of analytical methods both internally and to external vendors.
• Work with cross-functional groups including Research & Development, QC, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
• Analyze, track, and trend data to monitor analytical assays, ensure consistency in assay performance, and identify assay improvements throughout the assay life cycle.

Qualifications:

• PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 0-2 years of R&D / analytical development experience or Bachelor’s or Master’s degree with 10 years of relevant experience.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA, and IF/ICC.
• Experience with MoA, functional, or potency assay development is a preferred.
• Excellent organizational skills and ability to multi-task in a fast-paced environment.
• Team player with excellent oral and written communication skills.
• Ability to critically think though experimental challenges and troubleshoot.
• Knowledge of ICH/USP guidelines and experience with assay qualification/validation preferred.

The Beam facility in Research Triangle Park is looking for an experienced pharmaceutical electrician to fill the role of Facility Maintenance Technician with a focus on electrical systems, equipment, and services. This position supports start-up, manufacturing, and site services tasks, coordination of maintenance and site services vendors, and the execution and support of the preventive maintenance and reliability program. In addition to a strong maintenance background and service-oriented mindset, the ideal candidate should also possess the ability to schedule and collaborate with site leadership, vendors, manufacturing operators, quality, and validation.

Responsibilities:

• Coordinate and schedule vendors for maintenance and site services tasks focusing on electrical systems in addition to general facilities support utilities/system.
• Respond to and troubleshoot issues with facilities, utilities, site services, and equipment; special emphasis on generators, automatic transfer switches, panels, wiring, and electrical components of manufacturing and laboratory equipment.
• Assist with response to issues with calibrated instruments.
• Respond to alarms from the Building Automation and Process Control systems during business hours and in on-call rotation.
• Create individual work and review vendor work within the site CMMS system.
• Execute daily rounds and maintenance and reliability activities for plant utilities (Generator, ATS, Electrical, Chilled/Heating Hot Water, Compressed Air, etc.) and systems.
• Execute preventative maintenance programs internally or with 3rd party vendors.
• Review and suggest updates for Standard Operating Procedures for site and facility maintenance, electrical systems and power generation and backup equipment.
• Review the spare parts inventory program related to facility and electrical equipment/services. Coordinate as required with engineering, metrology and the I&C team.
• Ensure compliant operations in accordance with site cGMP, environmental, and federal / state requirements.
• Perform on demand work orders related to site services and engineering projects.
• Must be able to work onsite.

Qualifications:

• BS, Associate’s degree or equivalent experience in a technical discipline related to facility maintenance, construction, utilities, or trades.
• 8-10 years’ experience in maintenance within a biotech, pharma, or medical device manufacturing environment.
• Current NC Electrical License required.
• In-depth knowledge of electrical systems of various voltages.
• Computer literacy with experience in CMMS (Blue Mountain RAM Maximo, SAP, or other) Computerized Maintenance Management System.
• Strong background in cGMP manufacturing / operations knowledge. Siemens BAS and DeltaV experience preferred.
• Ability to manage competing priorities and timelines and adapt quickly to changing circumstances.
• High degree of customer service focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, humility, ownership, and drive.

Beam is seeking a highly-motivated Scientist/Senior Scientist to join our LNP Discovery group at our site in Cambridge, MA.

Primary Responsibilities:

• Design, synthesize, and characterize novel lipids, which will be used to formulate nanoparticles for encapsulation of base editor payloads.
• Discover and optimize new lipid components that drive the efficacy, selectivity, and safety of potential therapeutics.
• Help manage team of CRO chemists by providing synthesis targets, route troubleshooting, and feedback.
• Manage lipid inventory (physical stocks and electronic cataloging).
• Perform occasional bioconjugations linking lipid nanoparticles to auxiliary ligands.
• Work with other chemists, screening, and hit validation team members to facilitate smooth pipeline of testing novel lipid compositions.

Qualifications:

• Ph.D. in Chemistry (or related field) with 0-3 years industrial experience, or B.S./M.S. in Chemistry (or related field) with 8+ years industrial experience (job title commensurate with experience level).
• Documented track record of research focused in one of the following areas: organic chemistry, medicinal chemistry, or chemical biology.
• Skilled in multi-step organic synthesis and associated analytical techniques (column chromatography, mass spectrometry, NMR).
• Ability to analyze biological data and develop structure-activity relationships to guide design of new lipid analogs.
• Experience with lipid chemistry or bioconjugations could be advantageous, but is not required.
• An ideal candidate will demonstrate high levels of creativity, problem solving, and proficiency in organic synthesis.
• The ability to collaborate effectively throughout the company is also essential.

The Regulatory CMC Director will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead all regulatory activities to support high quality CMC sections of regulatory documentation.

Primary Responsibilities:

• Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/cell therapies.
• Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
• Act as the regulatory CMC lead and department representative in matrix teams for development programs.
• Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
• Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
• Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
• Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
• Develop regulatory processes and procedures to support CMC components of regulatory submissions.
• Support the creation and maintenance of CMC submission templates and dossier standards.
• Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
• Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
• Develops and maintains collaborative partnerships with key internal and external stakeholders.
• Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.

Qualifications, Knowledge and Skills:

• BA/BS degree in a scientific/engineering discipline.
• 10+ years experience in the biotech industry.
• 5+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
• Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
• Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
• Strong experience with CTD format and content regulatory filings.
• Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
• Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.