Associate Principal Scientist, Viral Vector Downstream Process Development

AstraZeneca is seeking a highly motivated and experienced Associate Principal Scientist in Viral Vector Downstream Process Development to support and expand our growing Cell Therapy and Gene Therapy portfolio. This role will play a critical leadership position in establishing robust, scalable, and phase‑appropriate lentiviral vector (LVV) downstream purification processes from early development through clinical and commercial readiness.

The successful candidate will lead matrixed project teams, act as a technical authority for LVV downstream purification, and partner closely with cross‑functional stakeholders including Research, Upstream PD, Analytical Development, CMC, Manufacturing, Quality, Regulatory, and external CDMOs.

Key Responsibilities

Downstream Process Development & Strategy

• Define, develop, and execute end‑to‑end LVV downstream purification strategies for ex vivo and in vivo applications with focus on yield, purity, potency, consistency, scalability, and cost.

• Establish platform‑aligned, phase‑appropriate purification processes suitable for IND‑enabling, clinical, and commercial manufacturing.

• Provide scientific leadership and technical oversight across clarification, chromatography, UF/DF (TFF), and sterile filtration operations.

Matrix Leadership & Project Execution

• Lead and influence cross‑functional, matrixed project teams, driving alignment on technical strategy, timelines, and decision‑making.

• Coach and guide scientists and engineers for the execution of downstream development activities.

• Ensure high‑quality experimental design, execution, data interpretation, and timely communication of results.

Scale‑Down Models, Scale‑Up & Technology Transfer

• Design and qualify representative scale‑down models to support process characterization and comparability.

• Support scale‑up to pilot, clinical, and commercial‑relevant equipment and consumables.

• Author, review, and approve technology transfer packages, and support successful implementation at internal GMP sites and external CDMOs.

CMC & Regulatory Enablement

• Contribute to and shape CMC downstream development strategies, including control strategy, in‑process monitoring, and operating ranges.

• Author and review CMC‑relevant documentation (development reports, batch records, process descriptions).

• Support preparation of regulatory submissions (e.g., IND).

Process Characterization, QbD & Risk Management

• Lead process characterization and platform studies, including DOE‑based investigations.

• Apply QbD principles, risk assessments (e.g., FMEA), and scientific justification to define design space and control strategy.

• Drive root cause investigations, troubleshooting, and continuous improvement initiatives.

Innovation & Continuous Improvement

• Identify and evaluate novel and next‑generation purification technologies (e.g., advanced chromatography, membranes, PAT/digital tools).

• Champion platform evolution, efficiency gains, and robustness improvements aligned with long‑term modality strategy.

Documentation, Compliance & Quality

• Ensure development activities adhere to cGMP concepts, data integrity, and Quality Systems expectations.

• Author and review protocols, reports, development summaries, and technical documents at a high standard of scientific and regulatory quality.

• Interface closely with Quality to ensure inspection readiness and compliance.

Qualifications

Education

• M.S. with 10+ years, or Ph.D. with 7+ years of hands‑on industry experience in downstream process development.

Technical & Industry Experience

• Extensive, hands‑on experience in LVV downstream process development (strongly preferred) or other viral vectors/biologics.

• Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration.

• Strong understanding of viral vector‑specific impurity profiles (HCP, host cell DNA, process residuals) and mitigation strategies.

• Experience supporting clinical and/or commercial scale processes, including tech transfer.

CMC, GMP & Regulatory

• Proven working knowledge of cGMP principles, Quality Systems, and relevant FDA/EMA guidance for gene and cell therapies.

• Direct experience contributing to CMC sections of regulatory filings.

Data, Statistics & Risk Tools

• Advanced experience with statistical analysis, DOE, and