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AstraZeneca · 2 days ago

Director, Viral Vector Process Development, Upstream

Gaithersburg, MD

Full-time

Onsite

Director/Executive

$173K/yr - $259K/yr

8+ years exp

AstraZeneca is looking for a highly motivated, experienced and strategic Director, Viral Vector Process Development (Upstream). This role will build and lead a high-performing function that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio, focusing on upstream design, development, and scale-up of Lentiviral Vector manufacturing processes.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Define and lead platform and product-specific LVV upstream processes optimized for suspension cell culture (e.g., stable producer or transient systems); drive innovations to improve titer, quality, robustness, and cost at pilot, clinical, and commercial scales

Design scale-up strategies from bench to 50–200 L single-use bioreactors; establish representative scale-down models for characterization and comparability; lead phase-appropriate validation and technology transfer to internal GMP sites and CDMOs

Oversee design, planning, and execution of upstream studies; identify CPPs/CMAs and establish design space using statistical DOE, MVDA, and PAT; implement and maintain a fit-for-purpose knowledge management system capturing process history, lessons learned, and control strategies

Build, lead, and develop a high-performing upstream PD team with deep expertise in suspension bioreactor operations; provide mentoring, training, and technical guidance; promote a culture of safety, scientific rigor, and continuous improvement

Represent upstream PD on program teams; drive timelines, resources, risk management, and decision-making to meet aggressive milestones; contribute to CMC strategy, control strategy definition, and regulatory interactions

Ensure generation of high-quality technical documentation (protocols, characterization reports, validation summaries, tech transfer packages, and regulatory CMC sections); implement fit-for-purpose systems and business processes aligned with corporate guidelines and cGMP principles for late-stage readiness

Perform process performance trending, root cause analysis, and corrective/preventive actions; establish and track KPIs (titer, infectivity, impurity profiles, cycle time, right-first-time); deploy Lean and digital tools for scheduling, data integrity, and reproducibility

Collaborate with internal partners and external suppliers/CDMOs; support sourcing and qualification of single-use suspension bioreactors, mixing systems, and critical raw materials (media, feeds, plasmids)

Qualification

Upstream LVV process developmentSuspension bioreactor expertiseGMP manufacturing operationsStatistical DOE applicationProcess automationRegulatory submissions experienceLean practices implementationTeam leadershipCommunication skillsProblem-solving skills

Required

Advanced degree (PhD) in Biochemical Engineering, Virology, Chemical/Biomedical Engineering, Biotechnology, or related field with 8+ years of relevant experience; or MS with 10+ years

Deep expertise in upstream LVV process development on suspension platforms, including scale translation to clinical/commercial, process characterization, and technology transfer; proven track record advancing programs from research through IND-enabling and into late-stage/GMP settings

Mastery of upstream unit operations for LVV in suspension (cell substrate selection and adaptation, transfection/infection strategies, media/feed optimization, bioreactor control, harvest/clarification interfaces) and application of statistical DOE and data analytics

Practical experience with cGMP manufacturing operations, phase-appropriate validation, and contributing to regulatory filings for US and ex-US markets

Ability to build and develop teams, influence in a matrix environment, and communicate complex technical concepts to diverse stakeholders; strong troubleshooting and problem-solving skills

Experience with single-use suspension bioreactors, process automation, PAT, and digital lab systems to accelerate development and ensure reproducibility

Preferred

Demonstrated success scaling suspension-based LVV processes to clinical and commercial production with sustained performance and continuous improvement

Familiarity with upstream–analytical linkages (titer, infectivity/potency, residuals/impurities) to guide process decisions and specifications; experience defining in-process controls for suspension systems

Experience preparing process/manufacturing sections of regulatory submissions and participating in health authority interactions for LVV programs

Track record implementing Lean practices and robust documentation/knowledge management in PD settings

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)