Sr. Manager, Analytical Sciences

Genetix Biotherapeutics•Somerville, MA

10h•$150,000 - $175,000•Onsite

About The Position

The Senior Manager, Analytical Sciences provides scientific and technical leadership for analytical activities supporting Genetix Biotherapeutics’ gene therapy portfolio across internal and external development and testing networks. This individual contributor role oversees analytical program execution, analytical lifecycle management, and the transfer and maintenance of analytical methods at external testing laboratories. It also serves as a key liaison with CDMO, CRO, and QC partners. The position maintains technical depth to support internal analytical activities, including hands-on assay development, troubleshooting, and characterization studies, while focusing primarily on analytical readiness, method performance, and strategic alignment across development and commercial testing environments. The role provides oversight of external laboratories, leads analytical method governance and lifecycle activities, and supports analytical strategy and control strategy development for clinical and commercial programs. It works cross-functionally with CMC, Process Development, Technical Operations, Quality, and Regulatory teams, and coordinates analytical deliverables and timelines with external testing partners. The position also contributes hands-on to method development, qualification, transfer, implementation, and characterization studies, and evaluates emerging technologies and platform improvements. This is a full-time, lab-based position at the Somerville, Massachusetts office. It requires onsite presence five days per week, is not eligible for remote or hybrid work, and requires candidates to live within a commutable distance of the office. The posted base salary range is $150,000–$175,000 USD; the role is also eligible for an annual bonus and long-term incentive.

Requirements

Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline, with at least 5 years of biopharmaceutical industry experience; or an M.S. with at least 8 years of relevant industry experience.
Proven success leading analytical method transfers, validations, investigations, lifecycle management, and external partner oversight in cell and gene therapy or biopharmaceutical environments.
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, such as cell-based potency assays, ELISA, UPLC, multicolor flow cytometry, or ddPCR/qPCR.
Exceptional verbal and written communication skills, including the ability to translate complex analytical data into actionable insights for cross-functional CMC teams.
Ability to provide technical oversight and support assay development, troubleshooting, and characterization studies.
Must reside within a commutable distance of the Somerville, Massachusetts office and work onsite five days per week.

Nice To Haves

Experience managing analytical activities across multiple external testing organizations is strongly preferred.
Prior hands-on experience with CD34+ cell lineages and/or viral vector characterization is highly preferred.

Responsibilities

Serve as the analytical lead for external testing laboratories, providing scientific oversight of analytical execution, method performance, lifecycle management, and continuous improvement.
Develop and maintain working relationships with CDMO, CRO, and contract testing partners to support consistent method execution and analytical performance.
Lead governance for analytical methods, including transfers, validations, investigations, revisions, trend monitoring, and change assessments.
Evaluate assay suitability across 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 a technical subject matter expert for troubleshooting, OOS/OOT investigations, and root-cause analyses with external partners.
Author method transfer protocols and oversee technical execution of method validation at external sites, ensuring regulatory compliance.
Collaborate across the CMC team to author and review technical reports, SOPs, and analytical data packages supporting IND/BLA submissions.
Provide technical leadership to internal and external testing organizations to ensure scientifically sound and compliant analytical activities.
Coordinate analytical deliverables, testing timelines, and resource planning across internal teams and external testing partners.
Provide technical oversight of analytical activities supporting development, characterization, comparability, and commercialization.
Implement laboratory analytical strategies aligned with process development milestones and regulatory guidelines.
Partner with Process Development, Technical Operations, Quality, Regulatory, and external testing organizations to support characterization, comparability, validation, and lifecycle management.
Identify, troubleshoot, and propose assay updates or modern replacements as part of analytical control strategy lifecycle management.
Execute and interpret characterization studies to inform data-driven decisions about process understanding and comparability.
Provide scientific leadership and hands-on technical contributions to analytical method development, qualification, transfer, and implementation.
Assess emerging analytical technologies and platform improvements that can enhance assay robustness, operational efficiency, and long-term sustainability.
Develop new methods with a right-first-time approach to support robust transition to a downstream GMP environment.