Drug Product Development Scientist Viral Vector

AstraZeneca is looking for a highly motivated and experiencedDrug Product Scientist for viral vector process development. The candidate will play a critical role in forming a high-performingteamthat accelerates AstraZenecas emerging Cell Therapy modalities portfolio. Youwill design execute andoptimizescalableLentiviral Vector (LVV)drug product formulation fill & finishprocesses with a primary focus onclinical and commercial scales. You will contribute hands-on to experimental design execution process characterization and scale-up/tech transfer activities from research throughIND 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) tosupportestablishdesign 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 2 years; OR B.S. with 4 years of handson 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: Practicalproficiencyin 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;demonstratedproblem-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 $92252.00 - $138378.00. Our positions offer eligibility for various incentivesan 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.