Director, External Manufacturing - Viral Vectors

AstraZeneca • Gaithersburg, MD

1d

About The Position

AstraZeneca is seeking a strategic, execution-focused Director, External Manufacturing – Viral Vectors to lead our external manufacturing network for viral vectors and plasmids in support of our growing Cell Therapy portfolio. This leader will own end‑to-end CDMO partnerships aligning external execution with AstraZeneca’s business objectives to deliver reliable, cost‑effective supply and technical robustness across preclinical, clinical, and commercial stages. The ideal candidate combines deep viral vector CMC/manufacturing expertise with strong vendor and program leadership, quality/regulatory acumen, and the ability to influence across a complex matrix. This role can be based in Gaithersburg, MD or Santa Monica, CA.

Requirements

• Advanced degree (PhD or MS preferred) in Biochemical Engineering, Biology, Virology, or related field.
• 10+ years in biopharmaceuticals with substantial experience in viral vector CMC, process development, and/or GMP manufacturing; direct LVV/AAV and plasmid experience strongly preferred.
• At least 5+ years managing external manufacturing/CDMOs for biologics or advanced therapies with demonstrated success from development through commercialization.
• Proven track record of tech transfer and commercial readiness for viral vectors; familiarity with cost modeling, capacity planning, and business case development for external manufacturing; strong program/project management of complex, multi‑site initiatives (PMP or equivalent a plus).
• Technical Expertise: Deep knowledge of viral vector production (e.g., transient transfection, producer cell lines), downstream purification, and analytics (potency, infectivity, vector genome, residuals). Familiarity with plasmid manufacturing (fermentation, purification, release testing) and control strategies for CRMs. Expertise in GMP, ICH guidelines, phase‑appropriate validation, PPQ, and change control; understanding of global regulatory expectations for viral vectors and plasmids.
• Leadership & Communication: Strong vendor management and relationship‑building skills with the ability to influence without authority. Excellent written and verbal communication—capable of conveying complex technical topics and driving alignment. Demonstrated problem‑solving, risk management, and decision‑making under time pressure; operates effectively in a fast‑paced, matrixed environment.

Responsibilities

• External Network Leadership: Establish, manage, and continuously improve a regional and global portfolio of LVV and plasmid CDMO partners. Align site capabilities with program needs and lifecycle stage in collaboration with CMC and Supply Chain; drive partnership health, performance, and strategic fit.
• Technical Stewardship (CMC/Manufacturing): Provide technical oversight across upstream, downstream, analytics, and aseptic fill‑finish. Review/approve process changes, comparability strategies, validation/PPQ plans, and lead or participate in joint technical governance with CDMOs.
• Process Development & Tech Transfer: Guide development and scale‑up strategies; plan and execute tech transfers between internal and external sites. Ensure process knowledge capture, control strategies, readiness for PPQ, and smooth handoffs across stages.
• Quality & Compliance: Partner with QA to ensure GMP compliance at CDMOs. Support audits, investigations, and CAPAs, and maintain alignment with global regulations and evolving guidance for viral vectors and plasmids.
• Supply Assurance & Operations: Partner with Supply Chain on supply plans, campaign scheduling, and capacity strategies. Monitor performance (e.g., OTIF, yield, deviations) and drive corrective and preventive actions to protect program timelines.
• Program & Project Management: Collaborate with cross‑functional teams to build integrated plans, critical paths, and risk registers; manage scope, dependencies, and timelines across multiple programs.
• Operational Excellence: Operate as a “virtual plant manager” for external sites—define and track KPIs, manage deviations/CAPAs, conduct periodic business reviews, and report delivery metrics and budget adherence.
• Regulatory Support: Contribute to CMC submissions (IND/IMPD/BLA/MAA) leveraging CDMO‑generated data. Ensure documentation quality, robust change control/justifications, and readiness for inspections.
• Continuous Improvement & Innovation: Identify opportunities to improve productivity, yield, cost, and cycle time. Introduce best practices, digital/analytics tools, and platform approaches for LVV and plasmids.
• Stakeholder Engagement: Build long‑term, trust-based partnerships with CDMOs and communicate effectively with internal stakeholders (CTDO, CMC, QA, Regulatory, Supply Chain, Finance) to drive aligned decisions.

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