The candidate will play a critical role in forming a high-performing team that accelerates AstraZeneca's emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector (LVV) drug product formulation, fill & finish processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, execution, 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- Formulation Development: Plan and perform experiments to develop new platform LVV formulations for ex vivo and in vivo applications.
- Fill and finish Development: Design, test, and support drug product fill and finish activities at pilot scale and clinical scale, including particle characterization, drug product filling, containers studies, stability, labeling and packaging etc.
- Tech Transfer Support: Develop representative DP scale-down models; support tech transfer to clinical, and commercial GMP sites.
- Process Characterization: Design and execute studies (including DOE) to support establish design space, conduct troubleshooting and root cause analysis, and recommend corrective actions.
- Novel Technologies & Continuous Improvement: Evaluate and implement next-generation drug product and formulation technologies 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: M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.
- Experience: Hands-on drug product development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale fill and finish.
- Technical Expertise: Practical proficiency in UFDF, formulation development, particle characterization, manual& automated drug product filling, container closure, and stability studies.
- 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 designing LVV or other viral vector/biologic formulation, fill and finish processes from preclinical to clinical/commercial-relevant equipment and consumables.
- Experience supporting tech transfer and implementation at internal sites and CDMOs.
- Familiar with regulatory requirement for biologic drug product.
The annual base pay for this position ranges from $118,870.40 - $178,305.60. 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 Posted28-Jul-2026
Closing Date03-Aug-2026
