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 AstraZenecas 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 onsuspension bioreactor platformsatclinical 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 forsuspension cell culture(e.g. stable producer or transient systems); drive innovations to improve titer quality robustness and cost atpilot clinical and commercial scales.

• Scale-Up Scale-Down and Tech Transfer: Design scale-up strategies from bench to 50200 L single-use bioreactors; establish representativescale-down modelsfor 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-purposeknowledge management systemcapturing process history lessons learned and control strategies.

• Team Leadership & Capability Building: Build lead and develop a high-performing upstream PD team with deep expertise insuspension 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 andcGMPprinciples 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 ofsingle-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 inupstream 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 ofstatistical DOEand data analytics.

• GMP Readiness: Practical experience withcGMPmanufacturing 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 withsingle-use suspension bioreactors process automation PAT and digital lab systems to accelerate development and ensure reproducibility.

Preferred Qualifications

• Clinical/Commercial Scale Delivery: Demonstrated success scalingsuspension-based LVV processesto clinical and commercial production with sustained performance and continuous improvement.

• Analytical Interface: Familiarity with upstreamanalytical 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 1020%) for cross-site collaboration vendor engagement and tech transfer activities.

The annual base pay for this position ranges from $172672.00 - $259008.00. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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 differenceapply today!

Compensation Pay Range:

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 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 program401(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

Closing Date

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