Sr Scientist, Analytical Sciences

Genetix Biotherapeutics; Somerville (MA); On-site; USD 127,000 - 164,000; Full time

Benefits offered by this job

Comprehensive health insurance

Employer-matched 401(k) plan

Flexible time-off

Tuition reimbursement

Paid parental leave

Job summary

Genetix Biotherapeutics is seeking a Senior Scientist in Analytical Sciences to lead technical efforts in supporting gene therapy product development. This role requires hands-on technical leadership in executing analytical testing and innovating new assays for internal development.

The successful candidate will also collaborate cross-functionally, ensuring compliance with regulatory standards and contributing to the technical transfer of methods to external laboratories. A strong educational background in Biochemistry or related fields with considerable industry experience is essential.

Qualifications

• 2–5 years of biopharmaceutical industry experience.
• Deep mastery of analytical techniques for gene therapies.
• Proven track record in developing and transferring assays.

Responsibilities

• Execute analytical workflows to support project milestones.
• Design and develop novel analytical assays for process optimization.
• Serve as technical lead for method transfers to QC laboratories.

Skills

Cell and gene therapy analytical techniques

Multicolor Flow Cytometry

ddPCR/qPCR

Cell-based Potency assays

ELISA

Technical communication

Education

Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or related discipline

M.S. with 6+ years relevant experience

Job description

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

Sr. Scientist, Analytical Sciences

SUMMARY

The Senior Scientist, Analytical Sciences will provide strong hands‑on technical leadership from the bench for the internal analytical development functions supporting our company’s gene therapy product portfolio. This individual contributor role will be responsible for designing and executing internal analytical testing for process development, innovating and qualifying new analytical assays, and leading the end‑to‑end technical transfer of these methods to external QC laboratories. The role will serve as a primary technical resource for process comparability studies and external investigations, partnering closely cross‑functionally within Technical Development and across Technical Operations.

This is a full‑time position requiring a strong on‑site laboratory presence in our Somerville office/laboratory.

RESPONSIBILITIES

Analytical Execution & Support

• Execute and manage analytical workflows internally to support day‑to‑day project milestones and pipeline progression.
• Implement analytical strategies within the lab to ensure tight alignment with process development milestones and regulatory guidelines.
• Partner closely with Process Development to provide rapid, high‑quality analytical testing for process optimization, routine characterization, and comparability studies.
• Contribute to the life cycle management of analytical control strategies by identifying, troubleshooting, and proposing assay updates or modern replacements.
• Provide the technical rigor and execute the characterization assays needed to support strategic, data‑driven decisions for process comparability.
• Lead from the bench in the design, development, qualification, and routine testing of novel analytical assays.
• Drive innovation in analytical platforms to improve assay sensitivity, throughput, and robustness, specifically tailored for complex cell therapies, including the implementation of bench‑top automation.
• Develop new methods with a "right first time" mentality to ensure seamless, robust transition to a downstream GMP environment.

Tech Transfer & Technical Investigations

• Serve as the primary technical lead for the successful transfer of analytical methods from the internal development bench to external QC testing laboratories.
• Author method‑transfer protocols and oversee the technical execution of method validation at external sites, ensuring compliance with regulatory standards.
• Act as the technical subject matter expert (SME) to support troubleshooting, OOS/OOT investigations, and root‑cause analyses with external CDMO/CRO partners.

Cross‑Functional Leadership & Compliance

• Collaborate across the CMC team to author and review technical reports, SOPs, and analytical data packages supporting regulatory submissions (IND/BLA).
• Serve as a technical anchor in the laboratory, leading by example with high standards of strict scientific rigor and operational excellence.
• Manage personal laboratory resource allocation, instrument maintenance, and testing timelines to ensure seamless program delivery.

QUALIFICATIONS

• Education: Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline with 2–5 years of biopharmaceutical industry experience; or an M.S. with 6+ years of relevant industry experience.
• Technical Expertise: Deep, hands‑on mastery of cell and gene therapy analytical techniques (e.g., Multicolor Flow Cytometry, ddPCR/qPCR, Cell‑based Potency assays, ELISA). Prior hands‑on experience with CD34+ cell lineages and/or viral vector characterization is highly preferred.
• Track Record: Proven success in developing, optimizing, and transferring assays to external CDMOs/CROs, as well as authoring technical reports used in regulatory filings. Strong troubleshooting capability for complex biological assays is essential.
• Communication: Exceptional verbal and written communication skills, with the ability to clearly translate complex, bench‑level analytical data into actionable insights for cross‑functional CMC teams.

Pay Transparency

$127,000 - $164,000 USD

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer‑matched 401(k) plan, lifestyle spending account, flexible time‑off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.