Executive Director, Process Engineering
AstraZeneca · Gaithersburg, MD
CMCFull-time$269k–$329kCompany career page
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Role summary
AstraZeneca seeks an experienced Executive Director of Process Engineering to lead cell therapy process engineering and build a new team. The role oversees design, scale-up, and optimization of manufacturing processes from development through commercialization, reporting to the Vice President of Analytical and Process Development.
What they're looking for
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or related field; or Master's degree with relevant industry experience
- 10+ years process engineering experience with 10+ years in leadership roles in biotechnology or pharmaceutical industry
- Cell therapy or biologics manufacturing experience including process design, scale-up, and optimization
- GxP compliance and data integrity knowledge
- Proven experience leading large, high-performing teams of 30+ members
- Expertise in CAR-T and human stem cell therapies, process development, transfer, and validation preferred
What you'll be doing
- Lead late-stage process development for cell therapies, managing multiple projects across several locations
- Create and deploy global technical standards for cell therapy processes, validation, sterility assurance, and packaging
- Design and oversee process validation, qualification, and monitoring strategies with master validation plans
- Build and manage multi-site organization supporting product portfolio and knowledge exchange
- Author and review regulatory CMC packages for IND filings and approval applications; address health authority inquiries
Privacy & handoff
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