Associate Director, Viral Vector Downstream Process Development
AstraZeneca
Summary
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.
Job description
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.
Requirements
- M.S. with 10+ years, or Ph.D. with 7+ years of hands-on industry experience in downstream process development
- 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
- 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
- Advanced experience with statistical analysis, DOE, and multivariate data interpretation
- Strong application of QbD, risk management, and process justification methodologies
- Excellent written and verbal communication skills
- Demonstrated ability to lead in matrixed environments, influence stakeholders, and resolve complex technical challenges
Benefits
- Short-Term Incentive Bonus
- Equity-Based Long-Term Incentive Program
- 401(k) Plan
- Paid Vacation
- Paid Holidays
- Paid Leaves
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.