Sr. Manager, Analytical Sciences

Summary

The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting our gene therapy product portfolio across internal and external development and testing networks. This individual contributor role will be responsible for overseeing analytical program execution, driving analytical lifecycle management, leading the transfer and maintenance of analytical methods at external testing laboratories, and serving as a key liaison with CDMO, CRO, and QC partners.

Tech Transfer & Analytical Lifecycle Management

• Serve as the analytical lead for external testing laboratories, providing scientific oversight of analytical execution, method performance, lifecycle management activities, and continuous improvement initiatives.
• Develop and maintain strong working relationships with CDMO, CRO, and contract testing partners to ensure consistent method execution and analytical performance.
• Lead governance activities related to analytical methods including transfers, validations, investigations, method revisions, trend monitoring, and change assessments.
• Evaluate assay suitability throughout the product lifecycle and identify opportunities for optimization, modernization, or platform replacement.
• Support analytical strategy and long-term control strategy development for clinical and commercial programs.
• Act as the technical subject matter expert (SME) to support troubleshooting, OOS/OOT investigations, and root-cause analyses with external CDMO/CRO partners.
• Author method transfer protocols and oversee the technical execution of method validation at external sites, ensuring compliance with regulatory standards.

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).
• Provide technical leadership across internal and external testing organizations to ensure scientifically sound and compliant execution of analytical activities.
• Coordinate analytical deliverables, testing timelines, and resource planning across internal teams and external testing partners to support program objectives.

Analytical Execution & Support

• Provide technical oversight of analytical activities performed internally and externally to support development, characterization, comparability, and commercialization objectives.
• Implement analytical strategies within the lab to ensure tight alignment with process development milestones and regulatory guidelines.
• Partner closely with Process Development, Technical Operations, Quality, Regulatory, and external testing organizations to ensure analytical support for process characterization, comparability, validation, and lifecycle management activities.
• Contribute to the life cycle management of analytical control strategies by identifying, troubleshooting, and proposing assay updates or modern replacements.
• Execute and interpret characterization studies to support strategic, data-driven decisions related to process understanding and comparability.

Assay Development & Innovation

• Provide scientific leadership and hands-on technical contribution toward analytical method development, qualification, transfer, and implementation activities.
• Assess emerging analytical technologies and platform improvements that enhance assay robustness, operational efficiency, and long-term sustainability across the testing network.
• Develop new methods with a "right first time" mentality to ensure seamless, robust transition to a downstream GMP environment.

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline with 5+ years of biopharmaceutical industry experience; or an M.S. with 8+ years of relevant industry experience.
• Proven success leading analytical method transfers, validations, investigations, lifecycle management activities, and external partner oversight within cell and gene therapy or biopharmaceutical environments.
• Experience managing analytical activities across multiple external testing organizations is strongly preferred.
• Demonstrated experience supporting analytical control strategies, method lifecycle management, trend monitoring programs, change control assessments, and regulatory inspections or filings.
• Deep, hands-on mastery of cell and gene therapy analytical techniques (e.g., Cell-based Potency assays, ELISA, UPLC, Multicolor Flow Cytometry, or ddPCR/qPCR).
• Prior hands-on experience with CD34+ cell lineages and/or viral vector characterization is highly preferred.
• 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.

This is a full-time, lab-based position located at our Somerville, Massachusetts office. The role requires an onsite presence five days per week and is not eligible for remote or hybrid work. Candidates must reside within a commutable distance of the Somerville office.