Senior Scientist, Viral Vector Process Development, Downstream

AstraZeneca • Gaithersburg, MD

2d • Onsite

About The Position

AstraZeneca is seeking a motivated and experienced Senior Scientist, Viral Vector Process Development (Downstream) to join their team. This role is crucial for building and leading a team focused on advancing AstraZeneca's Cell Therapy modalities portfolio. The successful candidate will be responsible for designing, executing, and optimizing scalable Lentiviral Vector (LVV) downstream purification processes for clinical and commercial scales. This position involves hands-on work in experimental design, process characterization, and scale-up/tech transfer, collaborating with various departments including Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. The role is based in Gaithersburg, MD.

Requirements

• 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.
• Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.
• 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.
• Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
• 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.
• Strong written and verbal communication; ability to work effectively in cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting skills.

Nice To Haves

• 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.

Responsibilities

• 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.
• Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges.
• 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.
• 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.
• Evaluate and implement next-generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.
• 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.
• 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree