Director, Development and Operations, Viral Vector New Modality

AstraZeneca • Gaithersburg, MD

1d

About The Position

AstraZeneca is looking for a highly motivated, experienced and strategic Director, Development and Operations to join our Viral Vector New Modality (VVNM) group. This role will build and lead a high-performing function that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. This role is responsible for establishing and operating state-of-the-art VVNM laboratories, delivering non GMP vector materials and core technical services, and partnering across CMC programs to ensure strategic alignment and execution from discovery through clinical and commercial stages. The ideal candidate combines deep viral vector expertise with operational excellence and cross-functional leadership. This position is based in Gaithersburg, MD.

Requirements

• Education: Advanced degree (PhD or MS) in Biochemical Engineering, Bioengineering, Virology, Molecular Biology, or related fields.
• Experience: 10+ years in biopharmaceutical development/manufacturing with viral vectors and/or cell therapy, including hands on process development and lab operations; 5+ years leading teams and cross functional programs.
• Technical Expertise: Strong knowledge of upstream and downstream viral vector unit operations and analytical methods.
• Safety & Compliance: Demonstrated leadership in biosafety for viral vectors, EHS policies, and fit for purpose quality frameworks for non GMP operations; familiarity with GMP principles and tech transfer to GMP settings.
• Program Leadership: Proven track record partnering with CMC, Regulatory, QA, and Clinical Supply to drive end to end development, risk management, and milestone delivery.
• Operational Skills: Experience in lab buildouts, equipment qualification, scheduling, capacity planning, and establishing service SLAs; proficiency with digital lab systems, inventory management, and data integrity practices.
• Soft Skills: Excellent communication, stakeholder management, and influence without authority; ability to operate in a fast paced, evolving environment and make pragmatic, data driven decisions.

Responsibilities

• VVNM Lab Build & Operations: Lead end to end lab setup and renovation; define facility and workflow requirements; oversee equipment selection, procurement, installation, qualification (IQ/OQ), and preventive maintenance. Establish biosafety/EHS programs for VVNM activities, implement scheduling and capacity management, and optimize sample logistics (chain of custody, inventory, cold chain, and data capture).
• Non GMP Core/Technical Services: Stand up and manage a core service supplying non GMP viral vector materials (research and tox grades) for internal programs. Define production platforms, scale ranges, and SLAs; drive basic analytical support for rapid PD iterations. Ensure robust documentation, release criteria, and traceability aligned with internal quality standards.
• CMC Program Management Partnership: Serve as the Process Development representative across research, IND-enabling, clinical, and commercial phases. Coordinate cross functional development activities to ensure strategic CMC alignment, risk management, and efficient execution. Contribute to CMC strategy, timelines, budget planning, and decision forums; enable seamless tech transfer between internal labs and external partners/CDMOs.
• People & Capability Building: Recruit, develop, and lead a multidisciplinary team with a culture of safety, scientific rigor, and continuous improvement. Establish training, competency matrices, and performance management.
• Quality, Compliance & Governance: Implement fit for purpose quality systems for non GMP operations; define documentation standards. Maintain audit readiness and alignment with biosafety/EHS regulations and corporate policies.
• Operational Excellence & Digital: Define KPIs for throughput, cycle time, and cost. Introduce Lean practices, visual management, and digital tools for scheduling, inventory, sample tracking, and data integrity.
• External Interface: Support vendor qualification and management for critical equipment, consumables, and CDMOs; contribute to make/buy analyses and strategic sourcing decisions.

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees