Associate Director, Aseptic Operations & Training (CGT)
Vertex Pharmaceuticals
12 days ago
On-site
Boston, MA
Operations
General Summary:
- 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 based at LC1, Boston.
Key Duties And Responsibilities:
- Build, lead, and mentor the team; foster a culture of compliance and continuous improvement.
- Assess capabilities, address skill gaps, and align team goals with organizational and regulatory requirements.
- Develop and deploy a GMP manufacturing training strategy using competency-based training.
- Own the Training Lab Facility and training staff for GMP onboarding and basic/advanced CGT process and aseptic skills.
- Oversee APS and APQ programs to meet CGT standards and US/International regulatory expectations.
- Serve as SME for contamination control strategies, GMP facility cleaning, material disinfection, sterilization, and cleaning validation.
- Develop, implement, and manage GMP training programs to ensure personnel competency.
- Lead initiatives to improve particulate control in single-use manufacturing systems.
- Ensure on-site support of aseptic behaviors and GMP training.
- Oversee regulatory compliance and inspection readiness; primary contact for GMP training strategy/program performance during inspections.
- Collaborate cross-functionally on process improvements and best practices.
- Monitor industry trends and track KPIs/metrics for continuous improvement.
Knowledge And Skills:
- Leadership in regulated environments; communication with regulatory authorities.
- Analytical problem-solving, strategic planning, adaptability, and strong decision-making.
- Strong knowledge of cGMP requirements.
- Excellent planning/organizational skills.
Education And Experience:
- Bachelor’s in Engineering, Microbiology, Biotechnology, or related; advanced degree preferred.
- 8+ years GMP manufacturing/process engineering leadership; 5+ years aseptic operations and training in CGT, biologics, or sterile filling.
- Expertise in drug product manufacturing, APS, APQ, GMP cleaning operations, sterilization/cleaning validation, and Annex 1.
- Experience managing GMP training programs, continuous improvement, digital transformations.
- Proficiency with eBR, DCS/SCADA, PI, ERP, QMS; paperless execution.
- Knowledge of investigations, CAPA, change control, and risk mitigation.
- 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 based at LC1, Boston.
Key Duties And Responsibilities:
- Build, lead, and mentor the team; foster a culture of compliance and continuous improvement.
- Assess capabilities, address skill gaps, and align team goals with organizational and regulatory requirements.
- Develop and deploy a GMP manufacturing training strategy using competency-based training.
- Own the Training Lab Facility and training staff for GMP onboarding and basic/advanced CGT process and aseptic skills.
- Oversee APS and APQ programs to meet CGT standards and US/International regulatory expectations.
- Serve as SME for contamination control strategies, GMP facility cleaning, material disinfection, sterilization, and cleaning validation.
- Develop, implement, and manage GMP training programs to ensure personnel competency.
- Lead initiatives to improve particulate control in single-use manufacturing systems.
- Ensure on-site support of aseptic behaviors and GMP training.
- Oversee regulatory compliance and inspection readiness; primary contact for GMP training strategy/program performance during inspections.
- Collaborate cross-functionally on process improvements and best practices.
- Monitor industry trends and track KPIs/metrics for continuous improvement.
Knowledge And Skills:
- Leadership in regulated environments; communication with regulatory authorities.
- Analytical problem-solving, strategic planning, adaptability, and strong decision-making.
- Strong knowledge of cGMP requirements.
- Excellent planning/organizational skills.
Education And Experience:
- Bachelor’s in Engineering, Microbiology, Biotechnology, or related; advanced degree preferred.
- 8+ years GMP manufacturing/process engineering leadership; 5+ years aseptic operations and training in CGT, biologics, or sterile filling.
- Expertise in drug product manufacturing, APS, APQ, GMP cleaning operations, sterilization/cleaning validation, and Annex 1.
- Experience managing GMP training programs, continuous improvement, digital transformations.
- Proficiency with eBR, DCS/SCADA, PI, ERP, QMS; paperless execution.
- Knowledge of investigations, CAPA, change control, and risk mitigation.