Job Description

General Summary:

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.

Key Duties and 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.

Knowledge and Skills:

• 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.

Education and Experience:

• 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.

Pay Range:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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