AstraZeneca
Executive Director, Process Engineering
$269K–$329K
US - Gaithersburg - MD · Director · Full-time · Posted Sep 5, 2024
- Experience
- 10+ years in process engineering preferred, including at least 10 years in a leadership role in biotechnology or pharmaceuticals focused on cell therapy or biologics.
- Education
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master’s degree with relevant industry experience.
About the job
Leads the cell therapy process engineering function, overseeing process development, validation, scale-up, transfer, and commercialization while building a multi-site team.
What you'll do
- Lead late-stage cell therapy process development projects and build a multi-site organization.
- Develop and oversee process standards, validation strategies, and transfer to GMP manufacturing.
- Lead regulatory CMC submissions and ensure compliance with applicable regulations and quality systems.
What they ask for
- Experience in cell therapy or biologics manufacturing, including process design, scale-up, and optimization.
- Knowledge of GxP compliance and data integrity.
- Proven experience leading large, high-performing teams; the posting specifies 30+ members.
- Demonstrated ability to develop manufacturing processes from scratch.
Nice to have
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field; alternatively, a Master’s degree with relevant industry experience.
- Expertise in CAR-T and human stem cell therapies, biologics, process development, transfer, validation, and automation.
Pay
USD $269,000 to $328,900 annual base salary
Tools
single-use technology, GMP, GxP, ISEC, HSE, CAR-T
Model-written summary · the original posting is authoritative