Associate Director, Manufacturing Training - Cell Therapy

We are looking for an experienced and passionate Associate Director, Manufacturing Training to lead the design, implementation, and continuous evolution of a high-impact training program within our Cell Therapy Manufacturing organization. This role is critical in ensuring operational readiness, compliance, and excellence as we grow life-changing therapies from the lab to the patient.

You will guide the end-to-end training strategy for manufacturing, including onboarding, skill development, and ongoing GMP compliance — with a focus on aseptic techniques, cleanroom behavior, and high-complexity, individualized production workflows. This is a collaborative role, partnering across Manufacturing, MSAT, Quality, Process Development, and Tech Transfer teams to support operational scalability. You will report to the Director, Manufacturing, Cell Therapy.
 

You Will:

• Lead the development of a comprehensive training program specific to cell therapy manufacturing operations, ensuring compliance with GMPband global regulatory requirements.

• Curate role-based curricula in partnership with Manufacturing, Quality, and Process Development leadership, ensuring understanding of evolving process requirements and regulatory expectations.

• Develop, and deliver technical training content on aseptic processing, cleanroom behavior, chain of custody/identity, and patient-specific workflows.

• Design and oversee the onboarding and qualification framework for new manufacturing personnel, ensuring rapid readiness for operations.

• Incorporate hands-on simulations, assessments, and mentorship programs to ensure confidence and capability in handling patient-derived materials.

• Be the site super user and SME for the Learning Management System (LMS) — Cornerstone.

• Ensure training records are current, audit-ready, and compliant with regulatory expectations through collaboration with the Quality organization.

• Monitor and report on training metrics to track compliance, identify gaps, and support inspection readiness.

• Lead creation and periodic review of engaging, relevant training materials and modules, incorporating adult learning principles and best practices.

• Update training programs to reflect changes in SOPs, manufacturing technologies, regulatory requirements, and process improvements.

• Apply Lean and Six Sigma principles to improve training effectiveness.

• Provide training support for tech transfer, new product introductions (NPI), and scale-up efforts by collaborating with Tech Ops and Process Engineering to ensure operational readiness.

• Play an active role in Area Operational Qualification (AOQ) and Area Process Simulation (APS) efforts, contributing training content and operator readiness strategies.

• Be the Business Process Owner for important GMP behavior programs, including gowning qualification, contamination control, and cleanroom etiquette.

• Promote a culture of quality, safety, and continuous learning on the manufacturing floor.
   

You Have:

• Bachelor's degree in Life Sciences, Engineering, or a related field; Master's degree preferred.

• Minimum of 8 years of experience in biopharmaceutical manufacturing, with a 3+ years in cell therapy and 3+ years in a training leadership role.

• In-depth understanding of GMP manufacturing principles, for autologous or allogeneic cell therapy products.

• Experience managing training programs in highly regulated, complex manufacturing environments.

• Proficiency in LMS platforms, especially Cornerstone.

• Project management and cross-functional collaboration skills.

• Lean Six Sigma certification or experience in continuous improvement methodologies is a strong plus.

• Exceptional communication, facilitation, and interpersonal skills.
   

Preferred Experience:

• Direct exposure to aseptic processing, closed-system manufacturing, or viral vector handling.

• Experience supporting regulatory audits and inspections (FDA, EMA, etc.).

• Familiarity with individualized product workflows and scheduling in a patient-centric manufacturing model.
   

The annual base salary for this position ranges from $124,000 to $186,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).