Associate Director, Manufacturing
About The Position
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. The role translates manufacturing strategy into operational execution and is accountable for safe, compliant, reliable patient-supply delivery, resource and workload management, leadership development, operating-model maturity, and future commercial readiness. The position oversees manufacturing performance across its assigned scope, including clinical supply delivery; safe, compliant, right-first-time execution; and readiness across personnel, equipment, facilities, materials, documentation, electronic systems, and training. It develops manufacturing leaders and teams, coordinates with cross-functional partners, supports capacity and workforce planning, and drives performance through operational metrics, escalation systems, action tracking, and continuous improvement. The role also supports technology transfer, engineering runs, new program introductions, manufacturing systems, inspection readiness, and preparation for scale-up and commercial manufacturing. It helps establish a culture of safety, quality, accountability, collaboration, inclusion, execution excellence, and patient focus. This is an onsite position, with work expected five days per week onsite and some flexibility in balancing in-office expectations with individual flexibility. The annual base pay range is $127,211.20–$190,816.80. The position is eligible for short-term incentive bonuses and equity-based awards. Benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage, subject to applicable plan terms.
Requirements
- Bachelor's degree in science, engineering, life sciences, business, or a related field, with 7–10 years of experience; significant confirmed experience or an equivalent combination of education and experience is also accepted.
- Extensive experience in GMP, biologics, pharmaceutical, biotech, 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.
Nice To Haves
- Experience in the production of cell-based therapies.
- Experience supporting clinical and commercial manufacturing operations.
- Experience with technology transfer, new program introduction, engineering runs, process-validation readiness, commercial readiness, or digital manufacturing systems such as MES.
- Experience in CMC development, biologics manufacturing, global operations, or multi-product manufacturing environments.
- Experience with paper and electronic batch records, MES, quality management systems, inventory systems, scheduling systems, or electronic quality systems.
- Experience developing operating models, shift structures, workforce plans, career ladders, direct-labor advancement frameworks, or succession plans.
- Experience applying Lean, 5S, standard work, tier management, SQDCP, visual management, operational excellence, or continuous-improvement tools.
Responsibilities
- Lead manufacturing operations across assigned teams, shifts, programs, or manufacturing areas.
- Oversee production of cell therapy products in accordance with applicable regulations, cGMPs, approved procedures, safety requirements, and site standards.
- Establish and maintain an operating model for safe, compliant, and predictable manufacturing execution.
- Build, mentor, and develop Manufacturing Managers, Leads, Specialists, and Associate Specialists.
- Ensure teams maintain appropriate training and qualifications for cell therapy GMP manufacturing in a multi-product clinical facility.
- Establish and maintain schedules for people, facilities, equipment, materials, documents, and electronic systems to support expected capacity.
- Drive performance using KPIs, SQDCP or SQSCP systems, tiered communication, Tier 2/Tier 3 escalation, 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 and 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.
- Embed safe work practices, GMP compliance, contamination control, inspection readiness, and patient safety in daily execution.
- Identify and mitigate risks to patient supply, product quality, schedule adherence, capacity readiness, and inspection readiness.
- Support and ensure timely closure of deviations, CAPAs, change controls, process transfers, OOS/non-conformance matters, and other business drivers.
- Review and approve assigned manufacturing documents, 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 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 for current and future manufacturing demand, including visual inspection and requalification requirements.
- Champion inspection readiness and ensure manufacturing behaviors, documentation, and cleanroom discipline meet internal and external audit expectations.
- Support organizational and shift structures, career pathways, succession planning, leadership bench strength, and direct-labor progression models.
- Ensure team communications 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 supporting Manufacturing operations, site strategy, and business objectives.
- Maintain manufacturing performance across the assigned site, program, or functional scope and deliver patient supply in line with clinical demand and business priorities.
- Manage and develop Manufacturing Managers and teams, including performance management and timely support and closure of manufacturing actions.
- Build readiness for scale-up, commercial manufacturing, inspection readiness, and future operating-model maturity.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Director
