Alexion Pharmaceuticals, Inc. · 1 day ago
Director, Development and Operations, Viral Vector New Modality
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Director/Executive
$173K/yr - $259K/yr
10+ years expAstraZeneca is looking for a highly motivated, experienced and strategic Director, Development and Operations to join their Viral Vector New Modality group. This role is responsible for establishing and operating state-of-the-art VVNM laboratories and ensuring strategic alignment and execution from discovery through clinical and commercial stages.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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)
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
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
Recruit, develop, and lead a multidisciplinary team with a culture of safety, scientific rigor, and continuous improvement
Establish training, competency matrices, and performance management
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
Define KPIs for throughput, cycle time, and cost
Introduce Lean practices, visual management, and digital tools for scheduling, inventory, sample tracking, and data integrity
Support vendor qualification and management for critical equipment, consumables, and CDMOs; contribute to make/buy analyses and strategic sourcing decisions
Qualification
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
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. 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
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2025-12-20
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