AstraZeneca
Director, Development and Operations, Viral Vector New Modality
AstraZeneca, Gaithersburg, Maryland, us, 20883
AstraZeneca is looking for a highly motivated,experiencedand strategicDirector, DevelopmentandOperationstojoinour Viral VectorNew Modality(VVNM)group.This rolewill build and lead a high-performing function that accelerates AstraZeneca’s emergingCell Therapymodalities portfolio. This roleis responsible forestablishingand operatingstate-of-the-artVVNM laboratories, deliveringnon 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 equipmentselection, 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 supplyingnon GMPviral vector materials(research and tox grades) for internal programs. Define production platforms, scale ranges, and SLAs; drivebasic analytical supportfor 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 acrossresearch, IND-enabling, clinical, and commercialphases. Coordinatecross functionaldevelopment activities to ensurestrategic 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: Implementfit for purposequality 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) inBiochemical Engineering, Bioengineering, Virology, Molecular Biology, or relatedfields.
Experience: 10+ years in biopharmaceutical development/manufacturing withviral vectorsand/or cell therapy, includinghands onprocess developmentandlab operations; 5+ years leading teams andcross functionalprograms.
Technical Expertise: Strong knowledge of upstream and downstream viral vector unit operations andanalytical methods.
Safety & Compliance: Demonstratedleadership inbiosafetyfor viral vectors, EHS policies, andfit for purposequality frameworks fornon GMPoperations; familiarity withGMPprinciples and tech transfer to GMP settings.
Program Leadership: Proventrack recordpartnering withCMC, Regulatory, QA, and Clinical Supply to driveend to enddevelopment, risk management, and milestone delivery.
Operational Skills: Experience inlab buildouts, equipment qualification, scheduling, capacity planning, andestablishingservice SLAs;proficiencywith digital lab systems, inventory management, and data integrity practices.
Soft Skills: Excellent communication, stakeholder management, andinfluence without authority; ability tooperatein a fast paced, evolving environment and make pragmatic,data drivendecisions.
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: 172,672.00 - 259,008.00 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 location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program[401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted 09-Jan-2026
Closing Date 29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Key Responsibilities
VVNM Lab Build & Operations: Leadend to endlab setup and renovation; define facility and workflow requirements; oversee equipmentselection, 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 supplyingnon GMPviral vector materials(research and tox grades) for internal programs. Define production platforms, scale ranges, and SLAs; drivebasic analytical supportfor 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 acrossresearch, IND-enabling, clinical, and commercialphases. Coordinatecross functionaldevelopment activities to ensurestrategic 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: Implementfit for purposequality 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) inBiochemical Engineering, Bioengineering, Virology, Molecular Biology, or relatedfields.
Experience: 10+ years in biopharmaceutical development/manufacturing withviral vectorsand/or cell therapy, includinghands onprocess developmentandlab operations; 5+ years leading teams andcross functionalprograms.
Technical Expertise: Strong knowledge of upstream and downstream viral vector unit operations andanalytical methods.
Safety & Compliance: Demonstratedleadership inbiosafetyfor viral vectors, EHS policies, andfit for purposequality frameworks fornon GMPoperations; familiarity withGMPprinciples and tech transfer to GMP settings.
Program Leadership: Proventrack recordpartnering withCMC, Regulatory, QA, and Clinical Supply to driveend to enddevelopment, risk management, and milestone delivery.
Operational Skills: Experience inlab buildouts, equipment qualification, scheduling, capacity planning, andestablishingservice SLAs;proficiencywith digital lab systems, inventory management, and data integrity practices.
Soft Skills: Excellent communication, stakeholder management, andinfluence without authority; ability tooperatein a fast paced, evolving environment and make pragmatic,data drivendecisions.
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: 172,672.00 - 259,008.00 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 location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program[401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted 09-Jan-2026
Closing Date 29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr