Senior LVV Manufacturing Leader - Hybrid (Somerville)

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 155,000 - 165,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid holidays

Parental leave

Commuter subsidy

Job summary

Genetix Biotherapeutics is seeking a Senior Manager, Lentiviral Vector Manufacturing to lead GMP LVV operations at our Somerville, MA site. You will drive manufacturing execution, batch review, CAPA management, and change controls in collaboration with Quality, Regulatory, MS&T, and Process Development.

You will serve as site liaison, own starting materials, and ensure on‑time delivery for commercial LVV manufacturing with occasional travel to CDMOs.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 6+ years in biopharma manufacturing.
• 3+ years in leadership roles.
• Experience with LVV manufacturing and CDMOs.
• Experience reviewing batch records and deviations, CAPAs, and change controls in GMP environment.

Responsibilities

• Provide operational oversight of GMP LVV manufacturing at the CDMO.
• Act as day-to-day site liaison for batch scheduling and issue resolution.
• Review and approve MBRs and batch records for GMP compliance.
• Own deviations and investigations related to commercial LVV manufacturing, ensuring root cause analysis and timely closure.
• Own CAPAs arising from manufacturing events, ensuring timely implementation and effectiveness checks.
• Author, review, and approve change controls affecting commercial LVV manufacturing.
• Review CDMO documentation impacting manufacturing operations; support inspections.
• Lead LVV and starting material meetings; collaborate with Quality, Regulatory, MS&T, Process Development, and Analytical teams.
• Foster accountability and collaboration; build strong relationships with CDMO counterparts.

Skills

Leadership

Cross-functional collaboration

Communication

Problem solving

Regulatory knowledge

cGMP knowledge

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Job description

Genetix Biotherapeutics is seeking a Senior Manager, Lentiviral Vector Manufacturing to lead GMP LVV operations at our Somerville, MA site. You will drive manufacturing execution, batch review, CAPA management, and change controls in collaboration with Quality, Regulatory, MS&T, and Process Development.

You will serve as site liaison, own starting materials, and ensure on‑time delivery for commercial LVV manufacturing with occasional travel to CDMOs.