Principal Cell Therapy Process Engineer, Global MS&T Equity

AstraZeneca; Gaithersburg (MD); On-site; USD 122,000 - 183,000; Full time

Job summary

AstraZeneca is seeking an experienced principal process engineer for our cell therapy Global Manufacturing Science and Technology (MSAT) team. The role centers on technical oversight of end-to-end manufacturing processes, technology transfer for pivotal clinical manufacturing, process validation strategy, and implementation of continuous improvements to enable commercialization across a global network.

The position is based in Gaithersburg, MD, onsite with up to 15% travel.

Qualifications

• Advanced degree in a relevant engineering field.
• Extensive experience in cell therapy/biologics/vaccines industry.
• Experience authoring and defending CMC sections for regulatory filings.

Responsibilities

• Oversee technology transfer and process characterization for cell therapy manufacturing.
• Provide lifecycle management oversight from pilot transfer to post-approval.
• Lead regulatory and quality support including CMC submissions and change controls.
• Collaborate with site MSAT, quality, CMC regulatory, and supply chain teams.

Skills

MSAT

Technology transfer

CPV

GMP compliance

Regulatory submissions

Education

Ph.D. in Chemical/Biochemical/Biomedical Engineering or related field

Job description

AstraZeneca is seeking an experienced principal process engineer for our cell therapy Global Manufacturing Science and Technology (MSAT) team. The role centers on technical oversight of end-to-end manufacturing processes, technology transfer for pivotal clinical manufacturing, process validation strategy, and implementation of continuous improvements to enable commercialization across a global network.

The position is based in Gaithersburg, MD, onsite with up to 15% travel.