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