Senior LVV Manufacturing Leader | Hybrid (Somerville)

Genetix Biotherapeutics; Somerville (MA); Hybride; USD 155 000 - 165 000; Plein temps

Avantages offerts par ce poste

Health and disability insurance

Employer‑matched 401(k)

Lifestyle spending account

Flexible time-off + holidays

Tuition reimbursement & loan repayment

Paid parental leave

Paid onsite parking

Commuter subsidy

Résumé du poste

Genetix Biotherapeutics in Somerville, MA is seeking a Senior Manager, Lentiviral Vector Manufacturing to lead GMP LVV production at the CDMO. You will manage MBR/batch review, deviations, CAPAs, change controls, and regulatory coordination.

Responsibilities include site liaison, starting materials management, and cross-functional collaboration with QA, Regulatory, MS&T, and Process Development. Hybrid role, with <10% travel and three on-site days per week.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 6+ years in biopharma manufacturing, with 3+ years in leadership.
• Hands-on GMP viral vector manufacturing experience preferred.
• Experience overseeing CDMOs and batch records in GMP.

Responsabilités

• Provide operational oversight of GMP LVV drug substance manufacturing at the CDMO.
• Review and approve MBRs and batch records for GMP compliance.
• Own deviations, investigations, CAPAs, and change controls.
• Lead LVV and starting material meetings, internally and externally.
• Support inspection readiness and participate in regulatory/customer inspections.

Connaissances

Cross-functional leadership

GMP experience

Lentiviral vector

CDMO oversight

Deviations & CAPAs

Change control

MBR review

Regulatory collaboration

Formation

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

Advanced degree preferred

Description du poste

Genetix Biotherapeutics in Somerville, MA is seeking a Senior Manager, Lentiviral Vector Manufacturing to lead GMP LVV production at the CDMO. You will manage MBR/batch review, deviations, CAPAs, change controls, and regulatory coordination.

Responsibilities include site liaison, starting materials management, and cross-functional collaboration with QA, Regulatory, MS&T, and Process Development. Hybrid role, with <10% travel and three on-site days per week.