The candidate will play a critical role in building a high-performing team that accelerates AstraZeneca's emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector LVV) downstream purification processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. This position is based in Gaithersburg, MD.
Key Responsibilities- Downstream Process Development: Plan and perform experiments to develop scalable, cost-effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency.
- Unit Operations Execution: Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges.
- Process Characterization & Data Analysis: Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root cause analysis, and recommend corrective actions.
- Scale-Up, Scale-Down & Tech Transfer Support: Develop representative scale-down models; support scale-up to pilot, clinical, and commercial-relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs.
- Novel Technologies & Continuous Improvement: Evaluate and implement next-generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.
- Documentation & Compliance: Author high-quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.
- Cross-Functional Collaboration: Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.
Qualifications - Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 0-2 years of industry experience; OR M.S. with 4-6 years.
- Experience: Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.
- Technical Expertise: Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.
- Data & Risk Tools: Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
- GMP & Regulatory: Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.
- Communication & Collaboration: Strong written and verbal communication; ability to work effectively in cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting skills.
Preferred Qualifications - Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial-relevant equipment and consumables.
- Experience supporting tech transfer and implementation at internal sites and CDMOs.
- Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.
- Demonstrated innovation in evaluating/implementing next-generation purification technologies.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca: Join a research-led organization where science and strategy meet to change clinical practice. You will work alongside experts who generate and communicate evidence that helps save lives, supported by a culture that values openness, shared learning, and the courage to try new ideas.
The annual base pay (or hourly rate of compensation) for this position ranges $92,252 - $138,378 USD Annual. 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 Posted10-Sep-2026
Closing Date
