AstraZeneca
Principal Scientist Drug Product Development
US - Gaithersburg - MD · Principal
Sponsorship not specified$184k-$276kDetected 1 day ago
GMPFDA RegulatoryCRISPRResearchAnimal StudiesLeadershipRegulatory Affairs
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odds of building a lasting career here
64Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
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About the role
- You will work with cross-functional teams and external partnerships to accelerate development timelines while ensuring product quality, scalability, and regulatory compliance.
- The annual base pay for this position ranges from $ 183,768.80 - $275,653.20.
Responsibilities
- 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.
- Lead development of fill-finish processes across pilot, clinical, and commercial scales.
- Drive implementation of advanced fill-finish technologies and automation solutions.
- 13-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
- 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.
Requirements
- Strong understanding of cGMP, Quality Systems, and lifecycle management principles.
- 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.
- Education
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioprocess Engineering, or related field with 12+ years of relevant industry experience
- M.S. with 15+ years of relevant industry experience.
- 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.
- Technical Expertise
- Deep knowledge of:
- Viral vector formulation development
Nice to have
- 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.
- In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
Compensation
- The annual base pay for this position ranges from $ 183,768.80 - $275,653.20.
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.
- Interface with Regulatory Affairs to support agency interactions and responses to health authority questions.
Equal opportunity
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.