Principal Scientist Drug Product Development
About The Position
AstraZeneca is seeking a strategic, innovative, and highly experienced Principal Scientist Drug Product Development, to support drug product development and platform strategy for our expanding Cell Therapy portfolio. This role will be responsible for establishing and advancing next-generation lentiviral vector (LVV) drug product platforms that support both ex vivo and in vivo CAR-T and other cell and gene therapy modalities. As a key scientific leader, you will define and execute drug product development strategies spanning formulation, fill-finish, characterization, stability, technology transfer, and regulatory support from early research through clinical and commercial manufacturing. You will work with cross-functional teams and external partnerships to accelerate development timelines while ensuring product quality, scalability, and regulatory compliance. This role requires strong technical depth in viral vector drug product development combined with demonstrated strategic thinking, long range planning, and the ability to influence across a complex matrix organization.
Requirements
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioprocess Engineering, or related field with 12+ years of relevant industry experience; OR M.S. with 15+ years of relevant industry experience.
- Extensive experience leading drug product development programs for lentiviral vectors, AAV, adenoviral vectors, vaccine products, or complex biologics.
- Proven track record advancing products from research through IND-enabling studies, clinical development, and commercialization.
- Experience managing external development and manufacturing partners.
- Deep knowledge of: Viral vector formulation development, UF/DF and drug product process development, Fill-finish operations and aseptic processing, Container closure systems, Particle characterization, Cryopreservation and cold-chain strategies, Stability program design and data interpretation, Technology transfer and process validation.
- Strong understanding of cGMP, Quality Systems, and lifecycle management principles.
- Experience supporting regulatory submissions and agency interactions.
- Familiarity with FDA, EMA, and global regulations for cell therapy, gene therapy, and biologics.
Nice To Haves
- Prior experience leading drug product development for commercial-stage cell or gene therapy products.
- Experience establishing platform technologies across multiple programs.
- Knowledge of emerging in vivo CAR-T and genetic medicine delivery systems.
- Experience authoring regulatory filings and supporting health authority inspections and audits.
Responsibilities
- Help to define and execute the long-term drug product platform strategy for lentiviral vectors supporting AstraZeneca’s In-vivo Cell Therapy pipeline.
- Establish scalable and robust drug product technologies that enable rapid progression from research through clinical and commercial manufacturing.
- Serve as the subject matter expert and scientific leader for viral vector formulation and drug product development.
- Lead the design, optimization, and characterization of novel LVV formulations for ex vivo and in vivo applications.
- Develop formulation strategies that maximize product stability, potency, infectivity, and manufacturability.
- Identify critical formulation attributes and establish platform approaches to support multiple therapeutic programs.
- Establish clinical and commercial drug product manufacturing strategies including filling, storage, packaging, labeling, and distribution.
- Lead development of fill-finish processes across pilot, clinical, and commercial scales.
- Oversee evaluation of container closure systems, cryogenic storage solutions, particle characterization methodologies, and shipping strategies.
- Drive implementation of advanced fill-finish technologies and automation solutions.
- Develop comprehensive drug product characterization strategies and analytical toolboxes.
- Establish stability-indicating methodologies and generate robust stability packages to support regulatory submissions and product shelf-life claims.
- Collaborate with Analytical Development to define critical quality attributes (CQAs) and product specifications.
- Support drug product technology transfer activities from development to GMP manufacturing sites and external CDMOs.
- Develop representative scale-down models and comparability strategies to support process transfers and lifecycle management.
- Partner with Manufacturing and Quality organizations to ensure successful process implementation and commercialization readiness.
- Provide technical oversight for drug product CMC sections of regulatory submissions, including INDs, IMPDs, BLAs, and MAAs.
- Interface with Regulatory Affairs to support agency interactions and responses to health authority questions.
- Ensure development activities are aligned with current FDA, EMA, and global regulatory expectations for cell and gene therapy products.
- Serve as the primary scientific lead for external collaborations, CDMOs, and technology partners.
- Evaluate emerging drug product technologies, formulation innovations, and manufacturing solutions.
- Drive adoption of novel approaches that improve productivity, robustness, quality, and speed-to-patient.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
- opportunity to receive short-term incentive bonuses
- equity-based awards for salaried roles
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What This Job Offers
Job Type
Full-time
Career Level
Principal
