Senior Cell Therapy Process Engineer, Global MS&T Leader

AstraZeneca; Gaithersburg (MD); On-site; USD 96,000 - 144,000; Full time

Job summary

AstraZeneca is seeking an experienced senior process engineer for our cell therapy Global Manufacturing Science and Technology (MSAT) team. This role supports technical oversight of end-to-end cell therapy manufacturing, leading technology transfer for pivotal clinical manufacturing and CPV strategies.

You will drive process improvements, contribute to validation and regulatory deliverables for commercialization, and collaborate across global manufacturing sites. Travel up to 10% is required.

Qualifications

• Ph.D. with 1+ yrs; or MS with 5+ yrs; or BS with 7+ yrs in cell therapy/biologics.
• Experience in GMP manufacturing, tech transfer, CPV.
• Experience in authoring CMC sections for regulatory filings (IND/BLA/MAA).
• Strong cross-functional collaboration and leadership capability.

Responsibilities

• Represent MSAT in technology transfer and process characterization for commercialization.
• Communicate operations needs to CMC team and ensure timely deliverables.
• Develop PPQ readiness and execute PPQ framework across sites.
• Implement CPV strategies to ensure process understanding and control.
• Lead global Change Controls and regulatory compliance activities.

Skills

Technology transfer

Process development

CPV knowledge

Regulatory collaboration

Education

Ph.D. in Chemical/Biochemical/Bioengineering

Job description

AstraZeneca is seeking an experienced senior process engineer for our cell therapy Global Manufacturing Science and Technology (MSAT) team. This role supports technical oversight of end-to-end cell therapy manufacturing, leading technology transfer for pivotal clinical manufacturing and CPV strategies.

You will drive process improvements, contribute to validation and regulatory deliverables for commercialization, and collaborate across global manufacturing sites. Travel up to 10% is required.