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 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. The annual base pay for this position ranges from $142,377.60 - $213,566.40. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 07-May-2026 Closing Date 21-May-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases. But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We're curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We're driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you'll do work that has the potential to change your life and improve countless others. And, together with your team, you'll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.