Associate Director, Aseptic Operations & Training (CGT)

Vertex Pharmaceuticals•Boston, MA

6d•Onsite

About The Position

We are seeking an experienced Associate Director, Aseptic Operations and Training – CGT to lead the Aseptic Operations and Training team within the Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering organization. This role is critical in building a high-performing team to support scalable clinical and commercial manufacturing across multiple Boston-area sites. The Associate Director will ensure compliance with global regulatory requirements, maintain audit-ready GMP facilities, and drive operational excellence in aseptic practices and training. This position reports to the Director, CGT Engineering Operations and is designated as on-site, based at LC1, Boston.

Requirements

Proven leadership in regulated environments with a focus on team development and operational excellence.
Strong communication and interpersonal skills, including direct interaction with regulatory authorities related to aseptic controls and strategies
Analytical problem-solving and strategic planning abilities.
Adaptability and sound decision-making in dynamic environments.
Strong knowledge of cGMP requirements for manufacturing
Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
Bachelor’s degree in Engineering, Microbiology, Biotechnology, or related field; advanced degree preferred.
8 years of progressive experience in GMP manufacturing or process engineering leadership, with at least 5 years of aseptic operations and training in CGT, Biologics, or Sterile filling operations.
Expertise in drug product manufacturing, APS, APQ, GMP cleaning operations, and sterilization/cleaning validation and complying with Annex 1 requirements in GMP manufacturing.
Experience managing GMP training programs, driving continuous improvement, and implementing digital transformations.
Proficiency in manufacturing systems (e.g., eBR, DCS/SCADA, Pi, ERP, QMS) and paperless execution strategies.
Strong knowledge of regulatory requirements, including investigations, CAPA, change control, and risk mitigation.

Nice To Haves

advanced degree preferred

Responsibilities

Build, lead, and mentor the Aseptic Operations and Training team, fostering a culture of compliance and continuous improvement.
Assess Manufacturing Operations and Support teams’ capabilities, address skill gaps, and align team goals with organizational and regulatory requirements.
Develop and Deploy a GMP Manufacturing Training Strategy that builds upon competency-based training principles and eliminates read and understand training approaches.
Responsible for the Training Lab Facility and training staff through which all GMP production personnel onboard and learn basic and advanced cell and gene therapy process and aseptic skills.
Oversee Aseptic Process Simulation (APS) and Aseptic Personnel Qualification (APQ) programs to ensure compliance with CGT standards and applicable US and International Regulatory expectations.
Act as SME for Contamination Control Strategies, GMP facility cleaning operations, material disinfection, sterilization, and cleaning validation processes.
Develop, implement and manage the GMP training program to ensure personnel competency in manufacturing and aseptic operations.
Lead initiatives to improve particulate control and prevention in single-use manufacturing systems.
Accountable for effective, on-site, support of aseptic behaviors and training in GMP operations.
Oversee regulatory compliance, inspection readiness, and serve as the primary contact for the GMP training strategy, program and performance during inspections.
Collaborate with cross-functional teams to drive process improvements and implement best practices.
Monitor industry trends in aseptic processing and cleaning technologies to ensure innovation.
Track and manage key metrics and KPIs to drive operational efficiency and continuous improvement.