Associate Director, Manufacturing

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.
• Ability to operate effectively in a fast-paced, complex, and changing manufacturing environment.

Preferred Qualifications

• Experience in the production of cell-based therapies.
• Supporting clinical and commercial manufacturing operations.
• Technology transfer, new program introduction, engineering runs, process validation readiness, commercial readiness, or digital manufacturing systems such as MES.
• CMC development, biologics manufacturing, global operations, or multi-product manufacturing environments.
• Paper and electronic batch records, MES, quality management systems, inventory systems, scheduling systems, or electronic quality systems.
• Developing operating models, shift structures, workforce plans, career ladders, frameworks for advancing direct labor, or succession plans.
• Applying Lean, 5S, standard work, Tier management, SQDCP, visual management, operational excellence, or continuous improvement tools.