Sr Scientist, Analytical Sciences

Genetix Biotherapeutics•Somerville, MA

13h•$145,000 - $155,000•Hybrid

About The Position

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. The ideal candidate will bring deep hands-on expertise in cell and gene therapy (CGT) analytical development, a proven track record of successful assay troubleshooting and tech transfers, and the scientific rigor required to bridge the gap between early scientific assay development and commercial QC operations.

Requirements

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.
Deep, hands-on mastery of cell and gene therapy analytical techniques (e.g., Multicolor Flow Cytometry, ddPCR/qPCR, Cell-based Potency assays, ELISA).
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.
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.

Nice To Haves

Prior hands-on experience with CD34+ cell lineages and/or viral vector characterization is highly preferred.

Responsibilities

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.
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.
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.