The candidate will play a critical role in building and leading 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 INDenabling, 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 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.
- 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.
The annual base pay for this position ranges from $108,473.60 - $162,710.40. 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 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.
Date Posted29-Jun-2026
Closing Date16-Jul-2026
