Principal Scientist Drug Product Development

AstraZeneca is seeking a strategic, innovative, and highly experienced Principal ScientistDrug 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.Key ResponsibilitiesDrug Product Platform Development StrategyHelp 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.Formulation DevelopmentLead 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.Fill-Finish and Drug Product Process DevelopmentEstablish 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.Product Characterization & StabilityDevelop 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.Technology Transfer & Commercial ReadinessSupport 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.Regulatory & CMC LeadershipProvide 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.External Partnerships & InnovationServe 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.QualificationsEducationPh.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioprocess Engineering, or related field with 12+ years of relevant industry experience; ORM.S. with 15+ years of relevant industry experience.ExperienceExtensive 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.Technical ExpertiseDeep knowledge of:Viral vector formulation developmentUF/DF and drug product process developmentFill-finish operations and aseptic processingContainer closure systemsParticle characterizationCryopreservation and cold-chain strategiesStability program design and data interpretationTechnology transfer and process validationRegulatory & QualityStrong 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.Preferred QualificationsPrior 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.The annual base pay for this position ranges from $183,768.80 - $275,653.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.Date Posted30-Jul-2026Closing Date13-Aug-2026Our 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.SummaryLocation: US - Gaithersburg - MDType: Full time