Longevity Industry Jobs

Intellia is looking for a Scientist focused on cell biology and assay development to support the advancement of genome editing products into the clinic. Within this role, you will be responsible for the implementation and execution of in vitro pharmacology data packages and generation of in vitro genotoxicity samples enabling in vivo and cell therapy program progression into clinical trials. You will be responsible for the documentation enabling regulatory filings including data documentation and quality control. In this role you will:

• Develop appropriate cell-based models and molecular assays to measure on-target editing, target mRNA and/or protein expression level.
• Work with research teams to transition relevant assays and methods from research into development through optimization to apply to regulatory programs implementing SOPs, standards, qualifications, etc
• Establish and write SOPs as well as communicate data through presentation and written documentation.
• Manage multiple workflow queues and requests.
• Conduct experiments, troubleshoot, and optimize independently and in collaboration with colleagues to meet deadlines.
• Accurately document project and sample information, protocols, and experimental details through the Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN).
• Write and QC technical and study reports to support regulatory filings (IND or CTA equivalent), and then synthesize the results for effective communication across various levels of expertise
• Partner with Project Management and PreClinical Genomics on strategy and execution of in vitro sample preparation in support of genotoxicity assays

About You

The Scientist, PreClinical in vitro pharmacology will have demonstrated expertise in cell biology, assay development, molecular biology, gene editing approaches, and experience in supporting gene editing therapies into the clinic.

• PhD with 0-3 years experience directly related to industry or a BS/MS with >8/>6 years of equivalent relevant experience
• Solid hands-on experience in cell culture techniques including primary cell culture. Primary hepatocytes experience is preferred.
• Assay development, optimization, and qualification experience
• Extensive knowledge of CRISPR gene editing approaches and genotoxicity assays.
• Experience with NGS is preferred
• Experience with liquid handling platforms (preferably Hamilton) is preferred.
• Experience in writing and documentation to support regulatory filings is preferred.

Meet Your Future Team

The PreClinical team is a fun, energetic, and passionate group of individuals focused on pre-clinical Genomics data support for regulatory packages. You will report directly to the Director of Pre-clinical in vitro Pharmacology. Given the breadth of work on this team, the candidate will have the opportunity to explore a wide range of areas within the Automation, Engineering, Genomics, Informatics, and Screening (AEGIS) groups.

The team is currently working mostly onsite to execute workflows in a wet-lab environment. Therefore, we require a candidate to be currently local to Cambridge MA, or open to relocating. While much of the day-to-day operations require managing wet-lab work, our team is focused on building not just technical expertise but fostering an environment for the growth of young scientists interested in a career in biotech. If you join our team, you can expect to join a hardworking, collaborative but flexible environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patients' lives. We instill a culture of teamwork, respect, inclusion, collaboration, and communication ensuring that each team member strives to reach their professional and personal potential.

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Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

The Medical Affairs Lead (MAL) NTLA-2001 is a MD/PharmD with solid history of clinical and pharmaceutical industry experience, ideally in the fields of cardiovascular or neurological diseases. The candidate will also have strong experience in product launches, including proven ability to translate and appropriately align commercial and medical goals and objectives. The MAL will be a key member of the Medical Affairs Leadership Team and report to the Head of Medical Affairs (HMA). This will be a highly visible role responsible for developing and leading medical affairs plans in close collaboration with cross-functional teams, contributing to clinical strategy, collaborating to develop impactful medical education, evidence generation and healthcare system and key stakeholders engagement plans. In addition, the Medical Affairs Lead will be accountable for operational oversight of execution of the plans.

You Will Be Responsible For The Following

• Co-lead the Integrated Brand Team for NTLA-2001, our lead investigational therapy for the treatment of ATTR amyloidosis, together and in close partnership with the Program Brand Lead.
• Responsible for the development of short-term and long-term strategy, as well as execution of the program medical affairs plan as a key component of the integrated brand plan and in full support of the key strategic imperatives.
• Accountable for the alignment of all global medical affairs activities in close partnership with other members of the Integrated Brand Team and Program Leadership Team.
• Accountable for the medical accuracy and fair balance of medical information in educational and other medical communication and learning materials for both internal and external use.
• Collaborate with other line functions (Clinical Development, HEOR, etc.) to ensure that the medical evidence generation plan is aligned with the NTLA-2001 program objectives.
• Engage with and prioritize key stakeholders identified as strategic partners, including advocacy groups, medical societies, payers, and provider groups as well as medical experts in ATTR amyloid cardiomyopathy and polyneuropathy.
• Work closely with Patient Advocacy, Medical Engagement and Regional Scientific Leads to develop and execute medical engagement strategy
• Play an integral role in the planning and participation of national and regional medical advisory boards.
• Provide medical input into the safety profile of the product in collaboration with Clinical Development and Patient Safety (PS) colleagues.
• Collaborate with all Medical Affairs functions and work closely with Access & HEOR to support key educational, engagement and evidence generation initiatives.
• Provide clinical support to the design and execution of HEOR studies, outcomes surveys, etc. in close collaboration with HEOR/Access colleagues.
• Work closely with Clinical Development team to ensure optimal collaboration and inclusion of external clinicians/KOLs and other relevant healthcare system stakeholders in clinical trial planning, enrollment, and interpretation
• Interact with investigators, KOLs, research institutions, and centers of excellence to oversee and support Medical Affairs objectives.
• Collaborate with the Scientific Communications team supporting the review and approval of publications and resources ensuring medical accuracy and alignment of all communication materials.
• Lead Intellia Medical Affairs initiatives at key congress meetings and conferences. This includes leading content development and presentation for internal and external medical education programs as needed.

About You

You are a key Medical Affairs leader who would embrace the challenge to create an innovative US and global Medical Affairs approach to support Intellia’s CRISPR/cas9 programs.

Qualifications

• MD/Pharm D with significant (>10y) experience in Medical Affairs and Clinical Development in the biotechnology/pharmaceutical industry.
• Experience in Medical Affairs leadership for products addressing rare diseases, with strong therapeutic area knowledge relevant to mechanism of action of NTLA-2001.
• Robust clinical research experience within the pharmaceutical/biotech industry.
• Previous experience successfully leading a medical affairs/clinical development team with responsibility for late-stage clinical studies across multiple regions.
• Solid communication, strategic, interpersonal, and negotiating skills, with ability to proactively predict challenges and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities.
• Knowledge of both regional and global Regulatory requirements.
• Track record of successful and emerging research in therapeutic areas relevant to Intellia’s development programs and pipeline.
• Demonstrated ability to lead and motivate a team; experience leading cross-functional teams and vendors/consultants.
• Demonstrated ability to present complex issues to upper-level management and contribute to executive level presentations and discussions.
• Excellent interpersonal skills with an ability to respond to multiple external and internal queries, managing and handling conflict constructively.
• Success working in a fast paced, matrixed, growing organization, partnering with multiple internal & external stakeholders.

Meet Your Future Team

The Medical Affairs Team at Intellia is here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe that Intellia has the right people, strategy, and culture to do it well. It is made up of outstanding professionals in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs.

The team is led by our Head of Medical Affairs, a physician scientist with over 25 years of experience in academia and industry drug development. Other senior team members have 10 or more years of similar experience, including many with prior direct experience in nucleic acid therapeutics and cell therapy.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Intellia Therapeutics is looking to hire a System Administrator to join our growing team. In this role, you will work closely with all areas of the organization, as well several external partners and suppliers. You will be responsible for the upkeep, configuration and reliable operation of the IT infrastructure which provides network computing services company-wide. You will provide proactive monitoring of the network, computing platforms, communications systems and other applications; proactively identifying problems and supporting the subsequent recovery of its infrastructure on a 24x7 basis. Additional responsibilities include:

• Support the Data Center Operations which includes data management, network support, Windows server administration, and maintenance
• Working with Azure Cloud and AWS cloud
• Install new software releases and system upgrades, evaluates and installs patches, and resolves software and hardware related problems
• A broad range of administrative functions including managing Active Directory and planning and deploying domain and security group policies
• Administration of Office 365, Okta Identity Management platform, Microsoft Intune, JAMF, Cloud Applications, Teams phone system and Meraki network devices, ISPs, and VPN
• Provide level 3 support for the desktop support team for issue escalation

About You

We are seeking an experienced Systems Administrator, with experience implementing IT systems such as: patch management, Helpdesk ticketing system, storage platforms and networks. Our ideal candidate will hold a Bachelor’s degree and can work autonomously on projects and be willing to take on new responsibilities. Additionally, candidates are encouraged to apply if they have experience with the following technologies: Windows 7/2016/2019, Microsoft Office Suite 2019, Active Directory, DNS, TCP/IP, DHCP, IIS, Office 365, ESXi 6.0/7.0, Cisco Meraki.

Meet Your Future Team

Reporting to the Associate Director, IT Operations, you will be joining cloud only infrastructure team The IT team is made up of individuals who bring a range of experience and knowledge to Intellia. While a small team, you will join a group of passionate individuals who enjoy working with one another.

The IT team is currently a mix of remote, hybrid, and onsite, and we are open to applicants working remotely for this role. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community. This includes virtual happy hours, team all-hands meetings, game nights, and more! You can expect to join a hardworking, collaborative environment.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

The Medical Affairs Lead (MAL) NTLA-2002 is a MD/PharmD with solid history of clinical and pharmaceutical industry experience, ideally in the fields of immunological disorders. The candidate will also have strong experience in product launches, including proven ability to translate and appropriately align commercial and medical goals and objectives. The MAL will be a key member of the Medical Affairs Leadership Team and report to the Head of Medical Affairs (HMA). This will be a highly visible role responsible for developing and leading medical affairs plans in close collaboration with cross-functional teams, contributing to clinical strategy, collaborating to develop impactful medical education, evidence generation and healthcare system and key stakeholders engagement plans. In addition, the Medical Affairs Lead will be accountable for operational oversight of execution of the plans.

You Will Be Responsible For The Following

• Co-lead the Integrated Brand Team for NTLA-2002, our lead investigational therapy for the treatment of Hereditary Angioedema, together and in close partnership with the Program Brand Lead.
• Responsible for the development of short-term and long-term strategy, as well as execution of the program medical affairs plan as a key component of the integrated brand plan and in full support of the key strategic imperatives.
• Accountable for the alignment of all global medical affairs activities in close partnership with other members of the Integrated Brand Team and Program Leadership Team.
• Accountable for the medical accuracy and fair balance of medical information in educational and other medical communication and learning materials for both internal and external use.
• Collaborate with other line functions (Clinical Development, HEOR, etc.) to ensure that the medical evidence generation plan is aligned with the NTLA-2002 program objectives.
• Engage with and prioritize key stakeholders identified as strategic partners, including advocacy groups, medical societies, payers, and provider groups as well as medical experts in ATTR amyloid cardiomyopathy and polyneuropathy.
• Work closely with Patient Advocacy, Medical Engagement and Regional Scientific Leads to develop and execute medical engagement strategy
• Play an integral role in the planning and participation of national and regional medical advisory boards.
• Provide medical input into the safety profile of the product in collaboration with Clinical Development and Patient Safety (PS) colleagues.
• Collaborate with all Medical Affairs functions and work closely with Access & HEOR to support key educational, engagement and evidence generation initiatives.
• Provide clinical support to the design and execution of HEOR studies, outcomes surveys, etc. in close collaboration with HEOR/Access colleagues.
• Work closely with Clinical Development team to ensure optimal collaboration and inclusion of external clinicians/KOLs and other relevant healthcare system stakeholders in clinical trial planning, enrollment, and interpretation
• Interact with investigators, KOLs, research institutions, and centers of excellence to oversee and support Medical Affairs objectives.
• Collaborate with the Scientific Communications team supporting the review and approval of publications and resources ensuring medical accuracy and alignment of all communication materials.

Lead Intellia Medical Affairs initiatives at key congress meetings and conferences. This includes leading content development and presentation for internal and external medical education programs as needed.

About You

You are a key Medical Affairs leader who would embrace the challenge to create an innovative US and global Medical Affairs approach to support Intellia’s CRISPR/cas9 programs.

Qualifications

• MD/Pharm D with significant (>10y) experience in Medical Affairs and Clinical Development in the biotechnology/pharmaceutical industry.
• Experience in Medical Affairs leadership for products addressing rare diseases, with strong therapeutic area knowledge relevant to mechanism of action of NTLA-2002.
• Robust clinical research experience within the pharmaceutical/biotech industry.
• Previous experience successfully leading a medical affairs/clinical development team with responsibility for late-stage clinical studies across multiple regions.
• Solid communication, strategic, interpersonal, and negotiating skills, with ability to proactively predict challenges and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities.
• Knowledge of both regional and global Regulatory requirements.
• Track record of successful and emerging research in therapeutic areas relevant to Intellia’s development programs and pipeline.
• Demonstrated ability to lead and motivate a team; experience leading cross-functional teams and vendors/consultants.
• Demonstrated ability to present complex issues to upper-level management and contribute to executive level presentations and discussions.
• Excellent interpersonal skills with an ability to respond to multiple external and internal queries, managing and handling conflict constructively.
• Success working in a fast paced, matrixed, growing organization, partnering with multiple internal & external stakeholders.

Meet Your Future Team

The Medical Affairs Team at Intellia is here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe that Intellia has the right people, strategy, and culture to do it well. It is made up of outstanding professionals in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs. The team is led by our Head of Medical Affairs, a physician scientist with over 25 years of experience in academia and industry drug development. Other senior team members have 10 or more years of similar experience, including many with prior direct experience in nucleic acid therapeutics and cell therapy.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Intellia is looking for a Director of PreClinical Genomics to support the advancement of genome editing products into the clinic. Within this leadership role, you will be responsible for the implementation and execution of on-target and genotoxicity data packages enabling in vivo and cell therapy program progression into clinical trials. You will be responsible for the documentation enabling regulatory filings including data documentation and quality control. This is a highly visible leadership position serving on multiple therapeutic program teams supporting regulatory filings and documentation. In this role you will:

• Manage a team of molecular biologists focused on the execution of genotoxicity data packages in support of regulatory filings and clinical programs
• Transition genomic assays from research into development through optimization and validation to apply to regulatory programs implementing SOPs, standards, etc
• Oversee data quality and writing of technical reports, genotoxicity addendums, briefing books, INDs, CTAs and other requests from global regulatory authorities
• Partner with computational biology, software engineering, and PreClinical Project Management on data analysis, data capture, and documentation
• Partner with Genomic Innovation to develop and align on- and off- target and genomic characterization assays to support pipeline programs and platform technology
• Serve as SME for genotoxicity assessment in support of in vivo and cell therapy development program advancement to the clinic
• Partner with PreClinical in vitro pharmacology on strategy for in vitro sample preparation in support of genotoxicity assays
• Effectively interact with other functional area experts in a program team environment to execute on the best course of action for genotoxicity assessment
• Partner with Toxicology on strategy and guidance for genotoxicity assessment for gene editing approaches
• Work with PreClinical Project Management to align resources and timelines
• Partner with regulatory, clinical, and program team leads to support regulatory filings
• Support the development of direct reports through coaching, mentoring, leveraging their strengths, and providing opportunities for career growth

About You

The Director of PreClinical Genomics will have demonstrated expertise in NGS and other sequencing methodologies, molecular biology, gene editing approaches and experience in supporting gene editing therapies to the clinic including engaging with health authorities both written and verbally.

• Ph.D. with 10 years directly related industry experience.
• Experience managing a high-performing team in a fast-paced environment.
• Experience juggling multiple high-priority projects and balancing resources.
• Experience in writing and documentation to support regulatory filings as well as response to health authority questions and interacting with health authorities.

Meet Your Future Team

You will be an SME for genotoxicity and gene editing products working closely with PreClinical in vitro pharmacology, Computational Biology, Toxicology, Genomics Innovation and PreClinical Project Management to support the development of genome editing-based therapeutics into the clinic. We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials.

In this key leadership role, you will report directly to the Vice President, Genomic Operations, who instills a culture of teamwork, respect, inclusion, collaboration, and communication ensuring that each team member strives to reach their professional and personal potential.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

We are looking for a Scientist in our growing team. If you are an independent problem-solver with a strong technical background in histology, and enjoy working in cross-functional teams, this is the role for you! As a Scientist, you will help support company’s various preclinical studies. In this role, you will:

• Guide scientists to collect tissues for histological analysis
• Conduct tissue processing, paraffin embedding, paraffin- and cryo-sectioning
• Develop and perform immunohistochemistry assay
• Develop and Perform RNAscope/Basescope in situ hybridization assay
• Develop and Perform various histological assay
• Digitize slides
• Conduct image analysis using software such as HALO, QuPath and imageJ
• Accurately document project and sample information, protocols, and experimental details through Electronic Lab Notebook to drive decision making across different teams

Qualifications

• Ph.D. in biology with 2+ years of academic or industry experience or B.S. in biology with 10+ years of histology experience
• Solid hands-on experience in the histology lab including tissue processing, paraffin embedding, sectioning, IHC, ISH, and whole slide scanning
• Experience with various tissue (liver, brain, bone, etc) is required
• Experience with Leica Bond Rx and spatial transcriptomics platforms is a plus
• Experience with HALO or QuPath is a plus
• Strong time management and process-oriented thinking

Meet Your Future Team

The Gene Editing Platform are a group of bright, fun, and team-first individuals. Eager to move cool projects forward, we are motivated at the opportunity to make an impact for patients. The breadth of exposure to cutting edge gene therapy development will provide you with exposure to the full spectrum of gene and cell-based therapies, starting from CRISPR guides to patients who we try our best to support. You will report to a Senior Principal Scientist who leading multiplatform imaging experiments from histology to molecular staining.

The team is currently working mostly onsite in a wet-lab environment. Therefore, we hope you are currently local to Cambridge MA, or open to relocating. While much of the day-to-day operations require wet-lab work, our team is focused on building not just technical expertise but fostering an environment for growth of scientists interested in a career in therapeutic biotechnology. If you join our team, you can expect to join fast, fun, exciting and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team together.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

We are looking for a talented Scientist to join Nuclease Engineering Team in Gene Editing Platform Group. You will be working on diverse Protein Engineering projects to advance our gene engineering capabilities that will enable the development of tailored therapies for complex genetic diseases. You will work on various screening methods and validate results using biochemical or cell biological methods. You will also have opportunities to collaborate with stakeholders in Ex Vivo and In Vivo platforms. Additional responsibilities include:

• Develop and execute high-throughput screening methods to improve proteins of interest with desirable characteristics
• Utilize biochemical, cell and molecular biology approaches to validate the function of engineered protein
• Design bacterial, mammalian expression constructs, and be able to deliver various biological payloads using different delivery modalities
• Design and perform next-generation sequencing experiments
• Perform comprehensive data analysis and troubleshoot experiments
• Present scientific findings in team meetings and cross-functional meetings
• Document experiments in a timely manner using electronic laboratory notebook system
• Comply with laboratory safety regulations

About You

You are a highly motivated, goal-driven person, who is genuinely excited about science and not afraid of new challenges. You have deep understanding in protein structure-function relationship, and experience in biochemical, cell-based assays.

• Ph.D in Biochemistry, Structural Biology or Cell/Molecular Biology with 2+ years of relevant experience, or MS with 5+ years of relevant experience (this can be adjusted depending on SAS or Scientist position)
• Hands-on experience in rational library design and screening of pooled libraries using bacterial or mammalian systems
• Hands-on experience in various quantitative and qualitative assays, such as Octet, MSD, enzyme kinetics assay, ELISA
• Experience with mammalian cell culture, FACS, and cell based assays
• Ability to do routine molecular biology techniques, such as PCR, NGS, protein expression
• Comprehensive knowledge in CRISPR-Cas9, computational biology, experience in NGS data analysis
• Organized, detail-oriented, and demonstrated independent thinker
• Excellent verbal and written communication, teamwork, and strong problem-solving skills

Meet Your Future Team

The Gene Editing Platform team is a group of highly motivated and collaborative scientists. This group is responsible for the development of CRISPR-Cas9 based gene editing tools to advance Intellia’s platform to enable curative therapies. As a part of the Platform Innovation function, you will have opportunity to broaden your experience with multiple-cutting edge gene therapy technologies.

The team is currently working mostly onsite to execute workflows in a wet-lab environment. Therefore, we require the candidate to be currently local to Cambridge MA, or open to relocating. Our team is focused on building not just technical expertise but fostering an environment for growth of scientists interested in a career in biotech and chemistry. If you join our team, you can expect to join a hardworking and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patient’s lives.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Join Intellia’s Information Technology department as our new Senior Manager, Helpdesk Support! In this role, you’ll be managing a team of helpdesk support engineers, which includes hiring, training, supervising, and developing your staff. You’ll also manage our external MSP program and act as a liaison between the vendor and Intellia. As a Senior Manager, you’ll be expected to lead and influence your team, leveraging on-the-job training and team building events to foster a culture of pride, empowering them not only to close to tickets, but to identify their root causes and take ownership of seeing them through until they are resolved.

This is an opportunity to have a voice and make an impact through your ownership of process improvements and your freedom to make decisions as it pertains to the work owned by the helpdesk support team. You’ll be expected to understand and monitor the KPI’s (key performance indicators) of the helpdesk ticketing system (Fresh Service) such as busy times, ticket volumes across engineers and categories, and make recommendations to improve efficiency and to identify and resolve backlogs and critical tickets. You’ll also oversee asset management and inventory of company equipment across the organization for both on-site and remote workers. Lastly, you’ll have opportunities to participate on various project teams, and lead and participate in cross-functional initiatives, especially with regard towards building a scalable and efficient technical infrastructure to support a rapidly growing company.

About You

A strategic thinker and self-starter with the ability to execute at a tactical level, your technical background combined with your previous experience managing a team will make you successful in this role. Although you love problem-solving and digging deep into technical issues, you’re also proud of your strong communication skills and enjoy playing a customer-facing role and speaking on behalf of your team.

A proven track record of success in building and/or managing a high-performing team is required.

Meet Your Future Team

Reporting to the Associate Director, IT Operations, you’ll be joining a dynamic and energetic team of 7 (with the possibility of expanding to 10 this year!) The Helpdesk Support team covers 5 buildings across our campus in Cambridge, MA. We also have a large population of hybrid workers as well as some who are fully remote who will require virtual technical support when they are not on-site. We are a highly collaborative and customer-service orientated group that isn’t afraid to roll-up their sleeves and get things done.

Helpdesk Support is a part of the larger IT Operations team, which is led by a highly technical leader who encourages his employees to take on new challenges to develop their skills and empowers them to be able to make decisions within the bounds of their role. You can expect to join a hard-working and passionate group of people who are working together to achieve one goal of bringing cures to patients.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

As an Associate Director in Potency Assay Analytical Development, you will join the Analytical Development team within the Technical Operations group and embrace the opportunity to transform amazing sciences and technologies into powerful cures.

Responsibilities Include

You will focus on leading a group of scientists in the development, troubleshooting, and qualification/validation of cell-based bioassays and immunoassays, for both gene and cell therapy-based programs, as well as the development of internal analytical capabilities to support in-house process development. To this end, you will be key in maintaining an evolving strategy across the cell and gene therapy platforms for early and late-stage potency assay development. You must have previous regulatory experience in filings and agency interactions.

• Lead, develop and mentor a group of scientists to effectively design, develop, optimize, transfer, qualify and/or validate novel cell-based bioassays and immunoassays for potency
• Draft and review SOPs, technical reports, and regulatory documents
• Represent AD and interact with a matrixed Tech Ops organization and other development teams to bring potency strategy forward
• Lead the transfer of analytical methods internally or to contract laboratories; manage internal experiments and trend internal method performance and specifications
• Lead potency comparability testing to support process changes and transfers.
• Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences, including regulatory agencies
• Act as a technical resource in investigations, health authority inquiries and regulatory filings
• Assess method performance, identify issues, and propose and implement appropriate remediation in conjunction with QA and company policies.
• Familiarity with statistical concepts and design of experiments (DoE) related to functional cell-based assay development, optimization, and validation.
• Familiarity with late-stage potency validation and ICHQ14 is highly desired

About You

Are you a motivated leader with organizational skills and drive? If you say yes, we encourage you to apply! Other qualifications and desired skills include:

• Ph.D. in Biochemistry, Cell Biology, or a related field with 5+ experience in an industrial setting leading and managing a team
• Experience working in a regulated pharmaceutical industry setting
• Gene and/or cell therapy experience is strongly preferred
• Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g., ELISA, MSD, flow cytometry and cell-based proliferation, phosphorylation, reporter and cytotoxicity assays)
• Knowledge of GMP as relevant to laboratory practices in sample handling and analysis of GLP and GMP samples
• Knowledge of industry USP/ICH guidance for the development, qualification/ validation of functional cell-based assays and potency methods

Meet your future team

The Analytical Development team is a group of Energetic, Brilliant, Fun and Motivated individuals. This group is responsible for developing robust and innovative analytical methods to support internal and external manufacturing processes. We support Intellia’s clinical programs as well as in vivo and ex vivo emerging pipelines. You will report to the Director of Bioassay and Potency within Analytical Development. She loves seeing people grow and develop and looks forward to learning from your experiences and building the team together.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

As a Principal Software Engineer, you will lead our Informatics Software group’s Experimental Design & Tracking (EDT) team producing software services while accelerating the pace of R&D. The EDT team is responsible for capturing the structured design of Intellia’s editing experiments and tracking samples through the NGS and screening lab. The data flowing through our cloud-based data systems enable the decisions driving Intellia’s programs. This is an opportunity to EXPLORE and DELIVER laboratory solutions that DISRUPT our industry and enable ONE Intellia’s advance in cutting-edge science. Main responsibilities include:

• Collaborate cross-functionally with genomics counterparts to deliver software solutions
• Work with the project manager to define, prioritize and schedule delivery to stakeholders
• Take ownership of the design and development of EDT team projects and service requests
• Lead a software engineering team to produce sample design & tracking solutions
• Invest heavily in the achievement of your team’s individual production and development goals

About You

You are an experienced leader of talented engineers toward the achievement of corporate objectives. As a seasoned engineer, you naturally recognize, propose, and produce solutions to workflow bottlenecks. You are a hands-on developer working side by side with your team during the implementation phase of projects. Our ideal candidate will have a BS/MS in Computer Science or a related computational discipline with experience in the biotech industry. We work as a team in a hybrid work environment and heavily utilize GitHub to manage work throughout the project workflow.

Skills And Technologies, You Should Be Familiar With Include

• Architect, develop and administer RDBMS databases storing genomic sample data
• Demonstrated experience developing RESTful APIs
• Utilization of an iterative approach to the SDLC
• Effective communication with stakeholders capturing project requirements
• Produce software design and well-documented action items from project requirements
• Produce clear and descriptive documentation for product end users
• Fluency in Python and related web frameworks
• Fluency with the shell in the Linux environment

In addition to the above skills experience, you will also interact with the following technologies.

• Work with the Infrastructure team to deploy data services to AWS
• Front-end development frameworks VueJS & Node
• LIMS or Laboratory Software, ELNs
• Microsoft Office suite of products including MS Office, MS Teams, Github

Meet Your Future Team

Informatics at Intellia consists of the Software and Computational Sciences teams. The computational scientist develops genomic pipelines while maintaining strict data integrity and quality standards. Software engineers work with their scientific counterparts to streamline workflows and create web-based data services with high regard for integrity and security. Additionally, the Software team performs development and operational functions for our AWS environment.

We are primarily remote with occasional laboratory visits when onsite testing is required. By utilizing modern collaboration platforms and tooling we have maintained a high level of productivity. If you join our team, you can expect to join a fast, exciting, and collaborative environment. We look forward to fostering your skills, learning from your experiences, and continuing to build an amazing team!

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

• Coordinate development of, and serve as principal writer for, clinical protocols/amendments, clinical study reports, investigator brochures, Module 2 summaries and other elements of regulatory submissions as well as abstracts, posters, and manuscripts
• Organize and lead document development and review meetings
• Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes
• Critically review statistical analysis plans to ensure alignment with anticipated data presentations in clinical study reports and Module 2 summaries
• Perform literature-based research to support writing activities
• Lead medical writing and cross-functional initiatives pertaining to document standards, template development, and processes

• At least 4 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
• A Bachelors, Masters, PharmD or Ph.D. in a life science or health discipline
• A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
• Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents
• Proficiency with templates and style guides
• Strong interpersonal, negotiation, verbal, and written communication skills
• Strong organizational and meeting skills and attention to detail
• Willingness and ability to take ownership of assignments, solve problems associated with medical writing deliverables, and determine when advice from management and others is necessary

• Work with scientific stakeholders to streamline genomics workflows
• Develop solutions on AWS
• Design dashboards to drive insight from experimental data
• Develop and utilize RESTful web services
• Communicate effectively with team members
• Iterative and agile approach to the SDLC

• Strong command of Python and an OOP language (e.g., C++, Java)
• Architect of a variety of databases including Columnar, RDBMS, NoSQL
• Hands-on experience with Workflow Orchestrators (Prefect, Airflow)
• Producer of well-documented GitHub repositories
• Familiarity through experience with AWS (SDKs, CLI)
• Building containerized services with Docker

• Anticipates internal and external regulatory information management challenges and recommends creative solutions
• Maintains current knowledge of regulations, best practices, and guidelines related to Regulatory technology and assesses impact on internal systems, tools, and processes
• Leads implementation and maintenance of Regulatory systems and tools partnering closely with IT and QA Validation to complete impact assessments, UAT, and manage user groups
• Administrator for Regulatory portals and gateways (e.g., SPOR, MHRA ICSR)
• Contributes to the writing, review, and implementation of standards and procedures related to Regulatory technology
• Teams up with other System/Business Administrations and Owners across Intellia to improve processes and align where necessary

• Anticipates and advocates for system enhancements and functionalities, and works with RIM team to map requirements to RIM program roadmap
• Manages the creation/maintenance of core and related objects, document/binder templates, reports/dashboards, and Commitments and HAQ databases
• Actively solicits and gathers feedback to understand evolving business requirements
• Translates feedback/requirements to workable RIM solutions including development of reports/dashboards, document/binder templates, and business requested system/process enhancements
• Provides technical expertise and guidance to users to ensure process adherence including workflows, document lifecyles, Submission Content Plans, etc.
• Implements training strategies, develops training materials, and delivers training for effective adoption of RIM
• Partners with Training and IT to ensure user accounts are created in a timely manner

• Bachelor’s degree with 6-8 years of combined Regulatory Operations and/or RIM experience (CMC submissions and Veeva Vault RIM experience/certification preferred)
• Strong understanding of RIM systems, SDLC, eCTD, Regulatory submission/document lifecycles
• Broad and comprehensive expertise in leading-edge Regulatory Information Management concepts

• Serve as the Global Regulatory Program Lead for one or more programs.
• Drive the development of regulatory strategy to enable initiation of clinical development and clarify the path to registration for novel gene therapies
• Interpret regulations, policies, and guidelines and advise cross-functional teams on regulatory requirements to support development
• Lead the planning, preparation (including authoring where relevant) and execution of regulatory submissions for assigned programs
• Represent regulatory on the program team and present to company committees as needed
• Serve as a liaison within internal departments at Intellia, with CROs, and with regulatory personnel at the various Health Authorities
• Keep abreast of changing regulations, guidance documents, and relevant technical/scientific developments
• Support other projects as assigned

• Understanding and interpreting complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and providing knowledge and expertise to guide the team on appropriate regulatory strategies
• Manage preparation and submission of high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW. This will require cross-functional interactions, excellent writing skills, as well as a good grasp of the underlying science
• Assuming direct point of contact with health authorities, lead transparent and proactive interactions with global health authorities
• Driving adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
• Partnering very closely with Nonclinical, Tech Ops, Quality, and Clinical groups to ensure the achievement of submission deadlines and obtain timely approvals

• B.S. in biochemistry, chemistry, biology, biochemical engineering, or related life science field,
• 8+ years of relevant biopharmaceutical industry experience (ideally with biologics experience in Regulatory Affairs)
• Expertise with drug development across all phases of clinical development is required as well as deep experience with global regulatory health authorities (e.g. FDA, EMA) and different submission types
• Preferred experience would include gene or cell-based therapeutics, RNA-based therapeutics, and/or orphan drug development
• Excellent written and verbal communication skills, including regulatory writing, are essential

• Provide leadership for document level submission readiness services and act as subject matter expert to assist on eCTD submissions including lifecycle management
• Provide regulatory advice and interpretation of submission regulations and guidance to the Intellia team.
• Provide mentoring, guidance, and building a highly functional operations team
• Responsible for the evaluation and selection of publishing outsource providers and leads the regulatory information management initiatives.
• Support all aspects of the submission, compilation, publishing activities including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers.
• Oversees vendor staff and manage the day-to-day work responsibilities related to submission compilation, publishing, electronic submission, and archiving.
• Manages, directs, and oversees the regulatory information management strategy, resources, and business practices.
• Makes critical decisions that capitalize on opportunities for optimization of information management technologies and effect positive change.
• Establish methods and procedures for tracking data quality, completeness, redundancy, and improvement.
• Assists with driving the corporate initiative workgroups related to Information Management Systems.

• Minimum of 10 years pharmaceutical industry experience with at least 3 years of supervisory experience.
• Minimum of 8 years of regulatory operations experience and in-depth first-hand experience with producing electronic submissions including eCTD/eSubmissions for all submission types in all regions.
• Strong familiarity with metadata management and associated processes.
• Working knowledge of pharmaceutical industry-related laws, regulations and submission guidance is essential.
• Direct experience in implementing regulatory systems, procedures, and decision support. Veeva RIM preferred
• Ability to proactively analyze issues and develop solutions
• Demonstrated ability to effectively manage multiple priorities and meet deadlines
• Expert knowledge and experience in compiling eCTD/eSubmissions.
• Expert knowledge of ICH guidelines.
• Expert knowledge of deploying Document Management Systems.

• Provide compliance support for activities at clinical sites including issue resolution, impact assessment and inspection readiness
• Collaborate with cross-functional teams, provide guidance and effective partnership to meet business priorities and its applicability for adequate quality oversight
• Manage supplier quality-related activities, including external compliance and audit support of CROs, specialty laboratories for Phase I-III programs
• Provide internal audit support related to systems, documents and functions
• Assist in establishing the organizational structure for the Clinical Quality Assurance function
• Prepare quality metrics for presentation to management
• Participate in the budget planning process for Quality Assurance

• BS/MS degree in a related scientific field with 8+/5+ years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry
• Previous Quality Assurance experience (5+ years) in clinical research /development preferred with a minimum of 3 years of Quality Assurance auditing experience
• Experience in developing/implementing Clinical Quality Assurance procedures
• Strong knowledge of global GCP regulations, guidances and standards
• Ability to analyze issues and resolve in a compliant manner
• Experience in GLP oversight is a plus
• Experience with eQMS is a plus
• Travel requirement: 0-20%

• Use best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment
• System based timeline management: Coordinate input, maintenance, and revision of the project plans for assigned projects, with escalation of unforeseen changes in resource demand, and project conflicts within a timely manner to Project Leadership
• Organize and maintaining team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies such as SharePoint, OneNote, and OneDrive

• A minimum of a BS degree
• Strong Project Management skills
• Strong teambuilding skills
• Strong verbal and written communication skills
• Highly organized, proactive
• Ability to proactively analyze issues and develop solutions
• Demonstrated ability to effectively manage multiple priorities and meet deadlines

• Develop and qualify bioassays for cell and gene therapy products using techniques like qPCR, ddPCR, MSD, ELISA
• Develop and qualify quantitative assays measuring process residual impurities
• Collaborate with the Process Development group to generate and analyze process development data to develop an understanding of product critical quality attributes to guide testing and process control strategies
• Analyze and present experimental data in team meetings, cross-functional meetings, and conferences.
• Participate in method transfer activities to vendors
• Manage junior Scientists

• BS/MS in biological sciences with 10+/ 8+ years, respectively, or Ph.D. with 2+ years of relevant work experience in industry
• Experience in developing analytical methods such as ddPCR, ELISA, MSD, or qPCR is required
• Experience in working with cell and gene therapy products and viral vectors preferred Understanding of assay development and qualification per FDA or ICH guidelines
• Experience in tech transfer of methods to GMP labs Understanding or knowledge of statistical tools such as ddPCR QuantaSoft, SoftmaxPro, JMP, PLA, etc.

• Supporting high throughput, SOP-driven cell-based screening assays for lead identifications using both manual and liquid handlers
• Execute cell and molecular biology experiments using a variety of approaches including transient transfection, electroporation, DNA extraction, RT-PCR, qPCR, flow cytometry, Western blot, ELISA
• Troubleshoot and optimize screening assays in collaboration with colleagues to meet deadlines
• Manage workflow queues and requests based on company priorities
• Accurately document project experiments in Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN)
• Author and review SOPs and other technical reports as requested

• MS in Molecular Biology, Biotechnology, or related field with 0-2 or more years of experience in an academic or industrial setting; BS with 2+ years of experience in related field
• Experience with one or more of the following: mammalian cell culture, transfection, electroporation, viral transduction, DNA extraction, RT-PCR, qPCR, Western blot
• Experience with automation and/or flow cytometry, are a plus
• Knowledge of CRISPR technology is a plus

• Serving as strategic thought partner to the Program Team Lead (PTL) and Program Management (PM) team partner, responsible for development and execution of program strategy in line with corporate strategy and goals
• Coordinate with PM team partner and PTL in creation, management, and communication of the Integrated Program Plan and the Global Development Plan (GDP) in partnership with the Program Leadership Team
• Facilitate cross-functional communication, and in partnership with the PTL and PM team partner, drive strategic and operational alignment with the program team, functional leads, alliance management, and Executive Leadership Team
• Facilitate strategic scenario planning discussions, develop risk/mitigation plans, and drive key program decisions through appropriate governance forums
• Participate in sub team meetings to manage agendas, minutes, action items, develop operational plans, and ensure overarching strategic perspective is represented in all discussions
• Support strategic & tactical program planning in partnership with Finance and Strategy/ Portfolio Management, to inform the long-range planning process, detailed investment planning, and portfolio prioritization exercises
• Monitor program financials, ensuring resources in place to support program goals, and escalate resource needs, where appropriate
• Ensure cross-functional and cross-program sharing of key learnings, and drive change management as applicable

• Direct experience in program management/program leadership for clinical stage development programs
• Proficient prioritizing and driving complex programs to milestone completion, with ability to translate complex operational details into big picture thinking
• Demonstrated proficiency in program management tools (e.g., Smartsheet, Microsoft Project), and methodology. Willingness to constantly improve PM tools, implement best practices, and foster change management
• Strategic and financial acumen with ability to develop and manage program plans, budgets, and timelines

• Setting clear direction and goals, ensuring the development and execution of program strategy is in line with corporate strategy and goals
• Oversee and drive the development and communication of the Integrated Program Plan and the Global Development Plan (GDP) in partnership with the Program Leadership Team and Program Management
• Facilitate cross-functional communication, drive strategic and operational alignment with the program team, functional leads, and Executive Leadership Team
• Facilitate strategic scenario planning discussions, and in partnership with PM work to identify critical issues, develop contingency plans
• Serve as the single point of accountability for the program team, and drive key program decisions through appropriate governance forums, where appropriate
• Build high performing teams, ensuring adequate resources in place to support Program Strategy, and in partnership with Functional Leadership resolve any team performance issues, working with line managers to develop team members
• Drive strategic & tactical program planning in partnership with PM partner, Finance and Strategy/ Portfolio Management, to inform the long-range planning process, detailed investment planning, and portfolio prioritization exercises
• Monitor program financials, ensuring resources in place to support program goals, and escalate resource needs, where appropriate