Associate Director, Manufacturing

About this role

The Associate Director, Manufacturing leads manufacturing operations for a site, program, shift structure, or major functional area supporting TCR T, CAR T, and allogeneic cell therapy programs. This role is accountable for translating manufacturing strategy into operational execution while ensuring safe, compliant, reliable delivery of patient supply, resource and workload management, leadership development, operating model maturity, and future commercial readiness!

Typical Accountabilities • Lead all aspects of manufacturing operations across assigned teams, shifts, programs, or manufacturing areas. • Lead operations related to the production of cell therapy products, ensuring adherence to applicable regulations, cGMPs, approved procedures, safety requirements, and site standards. • Establish and maintain an operating model that supports safe, compliant, predictable, manufacturing execution. • Build, mentor, and develop Manufacturing Managers, Leads, Specialists, and Associate Specialists. • Ensure teams maintain appropriate training and qualification levels for cell therapy GMP manufacturing in a multi-product clinical facility. • Ensure schedules for people, facility, equipment, materials, documents, and electronic systems are established and maintained to support expected capacity. • Drive manufacturing performance through KPIs, SQDCP or SQSCP systems, tiered communication, Tier 2/Tier 3 escalation, day-to-day execution rigor, and structured action tracking. • Establish department goals and ensure performance is tracked, reviewed, and acted upon. • Support capacity planning for clinical manufacturing, technology transfer, scale-up, installed capacity, employed capacity, shift structures, and future commercial manufacturing. • Partner with Quality, MSAT, Process Development, Supply Chain, EHS, Facilities and Engineering, Regulatory, HR, Training, and Site Leadership to ensure operational alignment. • Ensure safe work practices, GMP compliance, contamination control, inspection readiness, and patient safety are embedded into daily execution. • Identify and mitigate operational risks that could impact patient supply, product quality, schedule adherence, capacity readiness, or inspection readiness. • Ensure deviations, CAPAs, change controls, process transfers, OOS/non-conformance support, and other business drivers are supported and closed on time. • Review and approve key manufacturing documents as assigned, including SOPs, batch records, training materials, validation protocols, reports, and operational procedures. • Lead or support engineering runs, technology transfer runs, process implementation, new program introductions, and introduction of new manufacturing systems or digital tools. • Develop and implement programs to improve right first-time performance, timely delivery, release predictability, cycle time, and operational robustness. • Ensure sufficient qualified personnel are available to support current and future manufacturing demand, including visual inspection execution and requalification requirements. • Champion inspection readiness and ensure manufacturing behaviors, documentation, and cleanroom discipline can withstand internal and external audit scrutiny. • Support development of organizational structure, shift structure, career pathways, succession planning, leadership bench strength, and direct labor progression models. • Ensure communications delivered to the team are accurate, consistent, timely, and aligned with Manufacturing and site priorities. • Drive continuous improvement through staff engagement, operational excellence, standard work, visual management, 5S, problem solving, and data-based decision making. • Perform additional responsibilities and project-based assignments as needed to support Manufacturing operations, site strategy, and business objectives.

You Are Accountable For • Manufacturing performance across assigned site, program, or functional scope. • Delivery of patient supply in alignment with clinical demand and business priorities. • Safe, compliant, and right first-time execution across teams and shifts. • Capacity readiness across people, equipment, facility, materials, documentation, electronic systems, and training. • Effective leadership, development, and performance management of Manufacturing Managers and teams. • On-time support and closure of deviations, CAPAs, change controls, and manufacturing actions. • Cross-functional alignment involving Quality, MSAT, Process Development, Supply Coordination, EHS, Facilities and Engineering, Regulatory, Training, HR, and Site Leadership. • Establishing and maintaining a culture of safety, quality, accountability, collaboration, inclusion, execution excellence, Great Place to Work behaviors, and patient focus. • Building readiness for scale-up, commercial manufacturing, inspection readiness, and future operating model maturity.

Required • Bachelor's degree in science, engineering, life sciences, business, or related field with 7 – 10 years experience, significant confirmed experience, or equivalent combination of education and experience. • Extensive experience in GMP manufacturing, biologics manufacturing, pharmaceutical manufacturing, biotech manufacturing, or cell therapy manufacturing. • Experience leading multiple teams, shifts, managers, or functional areas. • Solid understanding of cGMP requirements, SOPs, batch records, quality systems, safety expectations, contamination control, and regulated manufacturing environments. • Experience with deviation investigations, CAPAs, change controls, SOPs, batch records, training programs, inspection readiness, and regulated documentation. • Proven ability to build teams, develop leaders, manage performance, coach leaders, and make difficult decisions. • Demonstrated ability to engage and influence in a matrixed environment. • Strong technical judgment, risk-based decision making, communication, problem solving, and operational leadership skills.

Similar jobs

• Senior Director, Manufacturing — Hyve Solutions · Fremont, CA
• Associate Director, Manufacturing Engineering & Industrialization — Becton Dickinson · USA RI - Warwick | USA GA - Covington BMD
• Senior Director, Manufacturing Operations — Firstquality · US GA Macon
• Senior Director, Manufacturing Operations — Elanco · Elwood, KS
• Director of Manufacturing — Andersen · Dubuque, IA
• Director of Manufacturing — Astro Mechanica · San Francisco
• Senior Manager/Associate Director, External Manufacturing — Obsidiantherapeutics · Bedford, MA (HYBRID)
• Assoc Director, Outsourced Manufacturing — Gilead Sciences · Foster City, California, United States