Senior Cell Therapy Process Engineer - Global MS&T

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

Job summary

AstraZeneca plc is seeking an experienced Senior Process Engineer for Global MSAT in cell therapy to oversee end-to-end manufacturing processes from tech transfer to lifecycle management. You will drive CPV, process validation strategy, and continuous improvement across a global network, ensuring regulatory readiness and high-quality deliverables.

The role requires working with cross-functional teams to support regulatory submissions, CPV strategies, and site-level implementation while traveling

Qualifications

• Ph.D. with 1+ years; OR MS with 5+ years, OR BS with 7+ years in cell therapy/biologics/ vaccines.
• Technical and hands-on expertise in cell therapy manufacturing processes and technologies.
• Background in GMP manufacturing operations and technology transfer.
• Experience in authoring CMC sections for major regulatory filings (IND/BLA/MAA) and inspections.
• High standards of quality, accountability, and urgency in a fast-paced cell & gene therapy field.

Responsibilities

• Represent Global MSAT in technology transfer and process characterization to enable commercialization of cell therapy products.
• Communicate Manufacturing Operations needs to the CMC team and ensure high-quality, timely deliverables.
• Develop PPQ readiness and execution framework for site MSAT teams and oversee site execution.
• Implement CPV strategies across sites to maintain process understanding and control.
• Lead lifecycle management from transfer to post-approval and drive process improvements.
• Contribute to regulatory risk management and standardize practices across sites.

Skills

Cell therapy

Technology transfer

CPV

GMP operations

Regulatory submissions

Education

Ph.D./MS/BS in Chemical/Biochemical/Biomedical Eng or related

Job description

AstraZeneca plc is seeking an experienced Senior Process Engineer for Global MSAT in cell therapy to oversee end-to-end manufacturing processes from tech transfer to lifecycle management. You will drive CPV, process validation strategy, and continuous improvement across a global network, ensuring regulatory readiness and high-quality deliverables.

The role requires working with cross-functional teams to support regulatory submissions, CPV strategies, and site-level implementation while traveling