Associate Director, Aseptic Operations & Training; CGT

Position: Associate Director, Aseptic Operations & Training (CGT)
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., e , DCS/SCADA, Pi, ERP, QMS) and paperless execution strategies.

* Strong knowledge of regulatory requirements, including investigations, CAPA, change control, and risk mitigation.

Pay Range:

$163,200 - $244,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting…