Director, Cell Therapy Quality & Lifecycle Strategy

AstraZeneca; Santa Monica (CA); On-site; USD 168,000 - 251,000; Full time

Job summary

AstraZeneca in Santa Monica, CA seeks a Cell Therapy Product Quality Leader to own end-to-end product quality strategy for autologous, allogeneic, and gene-edited therapies. Lead CMC inputs, lot release, stability, and risk management in a matrixed environment.

Role requires deep CGMP expertise, cross-functional collaboration, and regulatory acumen to ensure lifecycle continuity from clinical stages to commercialization. Based in Santa Monica/Tarzana with site manufacturing alignment.

Qualifications

• Bachelor’s or advanced degree in Life Sciences or Engineering (MS/PhD preferred).
• 10+ years in biotech/pharma with 3–5 years in CGT/Biologics leadership.
• Deep knowledge of global cGMP regulations (FDA, EMA, ICH) for clinical vs commercial products.
• Demonstrated record of authoring CTD sections for IND, BLA/MAA, and/or post-approval submissions.
• Expertise in analytical method validation, process development, tech transfer, and viral vectors (e.g. LVV).

Responsibilities

• Serve as the Quality representative on the CMC Team and lead the PQT sub-team.
• Liaise with the CMC Program Lead to communicate Quality deliverables, risks, and changes.
• Develop and implement the overall Product Quality Strategy and phase-appropriate control strategies.
• Own and maintain lot release and stability specifications for advanced cell therapy modalities.
• Manage the full specification lifecycle from clinical to post-approval maintenance.
• Support design and execution of analytical comparability studies for process/product changes.
• Oversee stability program for advanced cell therapy modalities with Global Stability.
• Review and evaluate major process changes for product safety and efficacy.

Skills

cGMP knowledge

CTD authoring

Analytical method validation

Tech transfer

Viral vectors LVV

Cross-functional leadership

Regulatory liaison

Product quality strategy

Education

Bachelor’s degree in Life Sciences or Engineering

MS/PhD preferred

Job description

AstraZeneca in Santa Monica, CA seeks a Cell Therapy Product Quality Leader to own end-to-end product quality strategy for autologous, allogeneic, and gene-edited therapies. Lead CMC inputs, lot release, stability, and risk management in a matrixed environment.

Role requires deep CGMP expertise, cross-functional collaboration, and regulatory acumen to ensure lifecycle continuity from clinical stages to commercialization. Based in Santa Monica/Tarzana with site manufacturing alignment.