AstraZeneca
Principle Process Engineer, Viral Vector Process Characterization and Commercialization
$122K–$183K
US - Gaithersburg - MD · Full-time · Posted Oct 25, 2026
- Experience
- PhD with 4 years, MS with 8 years, or BS with 10 years of relevant industry experience.
- Education
- BS, MS, or PhD in Chemical, Biochemical, Biomedical Engineering, BioEngineering, Biochemical Engineering, Biotechnology, Biochemistry, or a closely related discipline; advanced degree preferred.
About the job
Leads viral vector process characterization, validation, regulatory CMC authoring, and commercialization support for late-phase and commercial manufacturing.
What you'll do
- Lead or support process characterization, validation, PPQ, and continued process verification activities.
- Author and coordinate CMC sections for BLAs, MAAs, and other marketing applications, and support Health Authority responses.
- Support technology transfer, commercial readiness, lifecycle management, and inspection readiness with internal and external manufacturing partners.
What they ask for
- BS, MS, or PhD in a listed engineering, biotechnology, biochemistry, or closely related discipline.
- Relevant industry experience: PhD with 4 years, MS with 8 years, or BS with 10 years in cell therapy/biologics, vaccines, technical development, MSAT, or CMO management.
- Extensive GMP manufacturing operations and technology transfer background; experience in process validation and CPV.
- Experience authoring and defending CMC sections for major regulatory filings and regulatory inspections.
Nice to have
- Direct viral vector manufacturing and commercialization experience.
- Significant authorship responsibility for an approved or filed BLA, MAA, or other global marketing application.
Pay
$122,312.80 - $183,469.20 USD base salary
Tools
viral vectors, GMP, PPQ, CPV, BLA, MAA, CTD Module 3, FMEAs
Model-written summary · the original posting is authoritative