Job Summary
This role is responsible for managing the commercial GMP production of lentiviral vectors at a Contract Development and Manufacturing Organization (CDMO). The position entails ensuring readiness for production campaigns, reviewing batch records, handling deviations, overseeing corrective and preventive actions (CAPAs), managing change controls, and overseeing starting materials. The individual will collaborate with both internal teams and CDMO partners to ensure a consistent supply, compliance with regulations, enhancement of performance, and readiness for inspections.
Responsibilities
- Oversee the GMP manufacturing process for lentiviral vectors at the CDMO.
- Ensure campaign readiness and perform batch record reviews.
- Manage deviations and CAPAs to maintain quality standards.
- Handle change controls and oversee starting materials management.
- Work in coordination with internal and external teams to ensure a reliable supply of products.
- Ensure adherence to regulatory compliance and performance improvement initiatives.
- Prepare for and support inspection readiness activities.
Qualifications
- Bachelor’s degree in engineering, life sciences, or a related area; advanced degree is preferred.
- A minimum of six years of experience in biopharma manufacturing.
- At least three years in a supervisory or leadership position.
- Experience in GMP manufacturing and quality systems, particularly within viral vectors or cell and gene therapy.
- Strong skills in CDMO oversight and cross-functional leadership.
