Associate Director, Aseptic Operations & Training (CGT)
Vertex Pharmaceuticals
July 02, 2026
On-site
Boston, MA
Operations
General Summary:
We are seeking an experienced Associate Director, Aseptic Operations and Training – CGT to lead the Aseptic Operations and Training team within Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering. Ensure compliance with global regulatory requirements, maintain audit-ready GMP facilities, and drive operational excellence in aseptic practices and training. Reports to the Director, CGT Engineering Operations. On-site at LC1, Boston.
Key Duties And Responsibilities:
- Build, lead, and mentor the Aseptic Operations and Training team; foster compliance and continuous improvement.
- Assess capabilities, address skill gaps, and align team goals to organizational and regulatory requirements.
- Develop and deploy a GMP Manufacturing Training Strategy (competency-based; eliminate “read and understand”).
- Lead the Training Lab Facility and training staff for GMP production onboarding and aseptic/cell & gene therapy skills.
- Oversee APS (Aseptic Process Simulation) and APQ (Aseptic Personnel Qualification) programs.
- Act as SME for contamination control, cleaning operations, material disinfection, sterilization, and cleaning validation (including Annex 1).
- Develop, implement, and manage the GMP training program.
- Lead initiatives to improve particulate control in single-use manufacturing systems.
- Support aseptic behaviors and training in GMP operations.
- Own regulatory compliance/inspection readiness; primary contact for GMP training strategy and performance during inspections.
- Collaborate cross-functionally; monitor industry trends; track KPIs.
Knowledge And Skills:
- Leadership in regulated environments; team development and operational excellence.
- Strong communication/interpersonal skills with regulatory authorities.
- Analytical problem-solving, strategic planning, adaptability, sound decision-making.
- Strong knowledge of cGMP.
Education And Experience:
- Bachelor’s degree in Engineering, Microbiology, Biotechnology, or related field; advanced degree preferred.
- 8+ years GMP manufacturing or process engineering leadership; 5+ years aseptic operations and training in CGT/biologics/sterile filling.
- Expertise in APS, APQ, GMP cleaning, sterilization/cleaning validation.
- Experience managing GMP training programs, continuous improvement, digital transformations.
- Proficiency with manufacturing systems (eBR, DCS/SCADA, Pi, ERP, QMS) and paperless execution.
- Knowledge of investigations, CAPA, change control, risk mitigation.
Application Instructions:
Not provided in the text.
We are seeking an experienced Associate Director, Aseptic Operations and Training – CGT to lead the Aseptic Operations and Training team within Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering. Ensure compliance with global regulatory requirements, maintain audit-ready GMP facilities, and drive operational excellence in aseptic practices and training. Reports to the Director, CGT Engineering Operations. On-site at LC1, Boston.
Key Duties And Responsibilities:
- Build, lead, and mentor the Aseptic Operations and Training team; foster compliance and continuous improvement.
- Assess capabilities, address skill gaps, and align team goals to organizational and regulatory requirements.
- Develop and deploy a GMP Manufacturing Training Strategy (competency-based; eliminate “read and understand”).
- Lead the Training Lab Facility and training staff for GMP production onboarding and aseptic/cell & gene therapy skills.
- Oversee APS (Aseptic Process Simulation) and APQ (Aseptic Personnel Qualification) programs.
- Act as SME for contamination control, cleaning operations, material disinfection, sterilization, and cleaning validation (including Annex 1).
- Develop, implement, and manage the GMP training program.
- Lead initiatives to improve particulate control in single-use manufacturing systems.
- Support aseptic behaviors and training in GMP operations.
- Own regulatory compliance/inspection readiness; primary contact for GMP training strategy and performance during inspections.
- Collaborate cross-functionally; monitor industry trends; track KPIs.
Knowledge And Skills:
- Leadership in regulated environments; team development and operational excellence.
- Strong communication/interpersonal skills with regulatory authorities.
- Analytical problem-solving, strategic planning, adaptability, sound decision-making.
- Strong knowledge of cGMP.
Education And Experience:
- Bachelor’s degree in Engineering, Microbiology, Biotechnology, or related field; advanced degree preferred.
- 8+ years GMP manufacturing or process engineering leadership; 5+ years aseptic operations and training in CGT/biologics/sterile filling.
- Expertise in APS, APQ, GMP cleaning, sterilization/cleaning validation.
- Experience managing GMP training programs, continuous improvement, digital transformations.
- Proficiency with manufacturing systems (eBR, DCS/SCADA, Pi, ERP, QMS) and paperless execution.
- Knowledge of investigations, CAPA, change control, risk mitigation.
Application Instructions:
Not provided in the text.