Associate Principal Scientist, Viral Vector Downstream Process Development Full-time NEW

Associate Principal Scientist In 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 multivariate data interpretation.
• Strong application of QbD, risk management, and process justification methodologies.

Leadership & Collaboration

• Excellent written and verbal communication skills.
• Demonstrated ability to lead in matrixed environments, influence stakeholders, and resolve complex technical challenges.

Preferred Qualifications

• Track record of scaling LVV or viral vector purification processes from preclinical through clinical and commercial-relevant equipment.
• Experience supporting technology transfer to GMP manufacturing sites and CDMOs.
• Exposure to PAT, digital tools, and data/knowledge management systems.
• Demonstrated success in building and delivering next-generation purification processes end-to-end.