- Location
- Somerville, MA · Somerville, Massachusetts, United States
- Workplace
- Remote, Hybrid, Onsite
- Department
- Technical Operations
- Seniority
- Manager
- Education
- PhD
- Source
- Greenhouse
Description
About Genetix Biotherapeutics
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.
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. While maintaining sufficient technical depth to support and lead internal analytical activities, including hands-on assay development, troubleshooting, and characterization studies, the role is primarily focused on ensuring analytical readiness, method performance, and strategic alignment across development and commercial testing environments.
The ideal candidate will bring strong technical expertise in cell and gene therapy analytical development, a proven track record of assay troubleshooting, method transfer, and external partner oversight, and the scientific rigor required to bridge early development and commercial QC operations.
RESPONSIBILITIES
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 leveraging deep understanding of laboratory operations, assay execution, and analytical method performance.
- 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, leveraging internal and external capabilities as appropriate.
- 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
- Education: 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.
- Track Record: 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.
- Technical Expertise: 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.
- 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.
Additional Information
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
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.