Director, Viral Vector Process Development, Upstream

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. The role will lead end-to-end upstream design, development, and scale-up of Lentiviral Vector (LVV) manufacturing processes, with a primary focus on suspension bioreactor platforms at clinical and commercial scales. This leader will own upstream strategy and execution from research through IND-enabling and into late-stage readiness. The role operates in a highly collaborative, matrixed environment. The ideal candidate combines deep viral vector expertise with operational excellence and cross-functional leadership. This position is based in Gaithersburg, MD.

Key Responsibilities

• Upstream Strategy on Suspension Platforms: 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.

• Scale-Up, Scale-Down, and Tech Transfer: 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.

• Experimental Design & Characterization: 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.

• Team Leadership & Capability Building: 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.

• Cross-Functional Program Execution: 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.

• Documentation & Compliance: 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.

• Operational Excellence: 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.

• Stakeholder & Vendor Management: 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).

Qualifications

• Education: 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.

• Experience: 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.

• Technical Skills: 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.

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

• Leadership & Communication: 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.

• Tools & Automation: Experience with single-use suspension bioreactors, process automation, PAT, and digital lab systems to accelerate development and ensure reproducibility.

Preferred Qualifications

• Clinical/Commercial Scale Delivery: Demonstrated success scaling suspension-based LVV processes to clinical and commercial production with sustained performance and continuous improvement.

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

• Regulatory Contributions: Experience preparing process/manufacturing sections of regulatory submissions and participating in health authority interactions for LVV programs.

• Operational Excellence: Track record implementing Lean practices and robust documentation/knowledge management in PD settings.

Travel

• Ability to travel based on business priorities (approximately 10–20%) for cross-site collaboration, vendor engagement, and tech transfer activities.

The annual base pay for this position ranges from $172,672.00 - $259,008.00. 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. 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 pay (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.

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.