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).

Our Benefits:

Benefits offered include:

#celltherapy #LI-Onsite

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.