Job Description
General Summary
We are seeking an experienced Associate Director, Manufacturing Systems and Automation – CGT to lead the manufacturing systems and automation team within the Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering organization. This role is critical in developing the current team to support scalable clinical and commercial manufacturing across multiple Boston-area sites. The Associate Director is responsible for leading the strategy, implementation, integration, validation, and continuous improvement of GMP manufacturing systems supporting cell and gene therapy operations. This role provides technical and operational leadership for digital manufacturing initiatives focused on manufacturing execution, automation integration, electronic batch records, and end-to-end product traceability. This position reports to the Director, CGT Engineering Operations and is designated as on-site, based at LC1, Boston.
Key Duties and Responsibilities:
- Lead the design, implementation, integration, and lifecycle management of GMP manufacturing systems and automation platforms supporting cell and gene therapy manufacturing operations
- Develop and execute digital manufacturing strategies enabling real-time manufacturing execution, electronic workflow orchestration, automated data collection, equipment integration, process monitoring, manufacturing analytics and reporting
- Drive deployment and optimization of SCADA, MES, LIMS, OSI Pi, eBR, batch review by exception , release by exception, chain of custody/chain of identity, digital and smart manufacturing initiatives
- Lead cross-functional initiatives to improve manufacturing efficiency, system reliability, and data integrity
- Partner with enterprise IT and Quality Assurance to define exception management strategies, review workflows, and electronic approval requirements
- Drive reduction in batch review timelines and support accelerated batch disposition through exception-based review processes
- Lead implementation and governance of digital traceability systems supporting patient-specific autologous therapy manufacturing
- Ensure manufacturing systems and electronic release processes aligned with FDA GMP regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ data integrity requirements
- Ensure manufacturing systems maintain inspection readiness and compliance with global regulatory expectations
- Develop SOPs, governance standards, and lifecycle management procedures for manufacturing systems and automation platforms
- Track and manage key metrics and KPIs to drive operational efficiency and continuous improvement
Knowledge and Skills:
- Strong ability to simplify high-level concepts into actionable insights and advise on digital maturity, digital transformation and system integrations to the site leadership team
- 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
Education and Experience:
- Bachelor’s or master’s degree in engineering, Biotechnology, Automation, Computer Science, Life Sciences, or related discipline
- 7-10 years of progressive experience in GMP manufacturing or automation leadership, with at least 5 years of commercial digital/automation leadership in CGT, Biologics, or Sterile filling operations
- Strong implementation and commercialization experience in integrating first-of-kind equipment with manufacturing systems, automated batch review by exception, release by exception, chain-of-custody and chain-of-identification of autologous & allogeneic CGT products
- 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:
$160,000 - $240,000
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 subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
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.
#LI-Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
