External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy (Type 1 Diabetes)
Vertex Pharmaceuticals
- Boston, MA
- $152,000-228,000 per year
- Permanent
- Full-time
- Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
- Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
- Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities. It is anticipated that routine Person-in-Plant oversight will decrease over time.
- Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
- Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
- Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
- Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
- Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
- Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
- Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
- Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
- Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
- Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
- Lead continuous improvement initiatives to affect timely resolution of supply issues.
- Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
- Live the Vertex values.
- BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8+ years of relevant experience in biotech or pharmaceutical industries, working with or in cGMP facilities within the biotechnology industry.
- Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
- Strong technical background in aseptic manufacturing operations.
- Solid project management skills and experience managing complex projects.
- Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
- Strong leadership and an innate ability to collaborate and build relationships is critical.
- Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
- Flexibility to work shift hours required to cover critical process steps
- Ability to travel, national and international, up to 30%
- Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
- Solid experience in equipment and facility qualification and validation for ATMP CDMO’s
- Represent Vertex as a leader when issues arise.