Director, External Manufacturing - Viral Vector Technical Lead

AstraZeneca • Gaithersburg, MD

5d • Remote

About The Position

AstraZeneca is seeking an experienced, strategic and technically strong leader to join our team as Director, External Manufacturing – Viral Vector Technical Lead. Lentiviral vector experience is strongly preferred. The ideal candidate will possess deep expertise in lentiviral vector tech transfer, MSAT, process development, CMC, or GMP manufacturing, with proven ability to lead complex technical and strategic collaborations. This role is responsible for driving AstraZeneca’s external manufacturing network for lentiviral vectors and plasmids, ensuring the highest standards of quality, compliance, and operational excellence in support of the expanding cell therapy portfolio.

Requirements

• Advanced degree preferred in Biochemical Engineering, Biology, Virology, or related field.
• 10 years in biopharma with substantial experience in viral vector CMC, process development, tech transfer and/or GMP manufacturing; direct lentiviral vector and plasmid experience strongly preferred.
• 5+ years managing external manufacturing/CDMOs for viral vectors (lentiviral vector preferred); demonstrated success across development to commercialization.
• Track record of successful tech transfer and commercial readiness for viral vectors.
• Familiarity with cost modeling, capacity planning, and business case development for external manufacturing.
• Proven program/project management of complex, multi-site initiatives.
• Deep knowledge of lentiviral vector production, downstream purification, tech transfer to CDMO.
• Familiarity with plasmid manufacturing (fermentation, purification, release testing) and control strategies.
• Expertise in GMP, ICH guidelines, phase-appropriate validation, PPQ, and change control; understanding of global regulatory expectations for viral vectors and plasmids.
• Strong vendor management and relationship-building skills; effective at influencing without authority.
• Excellent written and verbal communication; ability to convey complex technical topics to diverse audiences and drive alignment.
• Demonstrated problem-solving, risk management, and decision-making under time pressure.

Nice To Haves

• Lentiviral vector experience is strongly preferred.

Responsibilities

• Direct and manage AstraZeneca’s external manufacturing network for lentiviral vectors and plasmids, focusing on technical partnerships with various CDMOs.
• Partner closely with internal stakeholders including process and analytical development, supply chain, CMC strategy, and program management functions to ensure alignment and seamless execution across the cell therapy portfolio.
• Serve as the primary subject matter expert for lentiviral vector CMC and manufacturing; review and approve process changes, comparability strategies, and validation plans; lead/participate in technical governance with CDMOs.
• Guide development and scale-up strategies at CDMOs; plan and execute tech transfers between internal/external sites; ensure process knowledge capture, control strategies, and PPQ readiness.
• Oversee and optimize relationships with external partners, ensuring robust program and vendor management, rigorous performance assessment, and accountability across technical and operational areas.
• Ensure best practices, high quality standards, and regulatory compliance in external manufacturing operations; proactively identify risks and drive continuous improvement.
• Lead and support technology transfers, process development, and troubleshooting, ensuring timely and efficient project execution.
• Contribute to CMC submissions (IND/IMPD/BLA/MAA) with CDMO-generated data; ensure documentation quality, readiness for pre-approval inspection, and robust change control/justifications.
• Identify opportunities to improve productivity, yield, cost, and cycle time; introduce best practices, digital/analytics tools, and platform approaches for LVV/plasmids.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director