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Director, Development and Operations, Viral Vector Modality

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: AstraZeneca
Full Time position
Listed on 2026-02-01
Job specializations:
  • Healthcare
    Healthcare Management, Healthcare Administration
Salary/Wage Range or Industry Benchmark: 150000 - 200000 USD Yearly USD 150000.00 200000.00 YEAR
Job Description & How to Apply Below
Position: Director, Development and Operations, Viral Vector New Modality

AstraZeneca is looking for a highly motivated,experienced and strategic

Director, Development and Operationstojoinour Viral Vector New Modality(VVNM) group.

This rolewill build and lead a high-performing function that accelerates AstraZeneca’s emerging

Cell Therapy modalities portfolio. This roleis responsible forestablishingand operating state-of-the-artVVNM laboratories, delivering non GMPvector 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 vectorexpertisewith operational excellenceandcross-functional leadership.

This position is based in Gaithersburg, MD.

Key Responsibilities
  • VVNM Lab Build & Operations:
    Leadend to endlab setup and renovation; define facility and workflow requirements; oversee equipment selection, procurement, installation, qualification (IQ/OQ), and preventive maintenance. Establishbiosafety/EHSprograms for VVNM activities, implement scheduling and capacity management, andoptimizesamplelogistics(chain of custody, inventory,cold chain, and data capture).
  • Non GMPCore/Technical Services:
    Stand up and manage a core service supplying non GMPviral 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 fornon GMPoperations; 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.
Qualifications
  • Education:

    Advanced degree (PhD or MS) in Biochemical Engineering, Bioengineering, Virology, Molecular Biology, or related fields.
  • Experience:

    10+ years in biopharmaceutical development/manufacturing withviral vector sand/or cell therapy, including hands onprocess developmentandlab operations; 5+ years leading teams andcross functional programs.
  • Technical Expertise:
    Strong knowledge of upstream and downstream viral vector unit operations and analytical methods.
  • Safety & Compliance:
    Demonstrated leadership inbiosafetyfor viral vectors, EHS policies, andfit for purpose quality frameworks fornon GMPoperations; familiarity with

    GMPprinciples and tech transfer to GMP settings.
  • Program Leadership:
    Proven track record partnering with

    CMC, Regulatory, QA, and Clinical Supply to driveend to end development, risk management, and milestone delivery.
  • Operational

    Skills:

    Experience inlab buildouts, equipment qualification, scheduling, capacity planning, andestablishingservice SLAs;proficiency with digital lab systems, inventory management, and data integrity practices.
  • Soft Skills:

    Excellent communication, stakeholder management, and influence without authority; ability tooperatein a fast paced, evolving environment and make pragmatic,data driven decisions.

At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally, working together to push the boundaries of supply chain excellence.

With a focus on sustainability and a commitment to doing things the right way, we offer opportunities for growth and development in a supportive environment.

Join us in making a difference—apply today!

Compensation Pay Range:

-  USD Annual

The annual base pay (or hourly rate of compensation) for this position is outlined above. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market…

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