This role will be a key part of 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 lead upstream process development 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 Lead on Suspension Platforms: 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: Provide mentoring, training, and technical guidance to the other junior team members; promote a culture of safety, scientific rigor, and continuous improvement.
- 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 6+ 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 lead 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 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.
The annual base pay for this position ranges from $138,392.80 - $207,589.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted08-Jun-2026
Closing Date25-Jun-2026
