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AstraZeneca · 1 day ago

Director, Development and Operations, Viral Vector New Modality

Gaithersburg, MD

Full-time

Onsite

Director/Executive

$173K/yr - $259K/yr

10+ years exp

AstraZeneca is looking for a highly motivated and experienced Director, Development and Operations to join their Viral Vector New Modality group. This role is responsible for building and leading a high-performing function that accelerates the Cell Therapy modalities portfolio, overseeing laboratory operations, and ensuring strategic alignment across CMC programs.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

Viral vector expertiseLab operations managementProcess developmentCross-functional leadershipBiochemical EngineeringSafety & ComplianceOperational ExcellenceDigital lab systemsStakeholder managementInfluence without authorityCommunication

Required

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

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

Strong knowledge of upstream and downstream viral vector unit operations and analytical methods

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

Proven track record partnering with CMC, Regulatory, QA, and Clinical Supply to drive end to end development, risk management, and milestone delivery

Experience in lab buildouts, equipment qualification, scheduling, capacity planning, and establishing service SLAs; proficiency with digital lab systems, inventory management, and data integrity practices

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

Benefits

Short-term incentive bonus opportunity

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

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)