Senior Viral Vector Process Engineer — PPQ, CMC & Commercialization

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

Job summary

AstraZeneca in Gaithersburg, MD seeks an experienced Principal Process Engineer to lead late-phase process development, characterization, and PPQ readiness for viral vector manufacturing. This individual will provide technical leadership across internal and external sites, with a focus on regulatory submissions and lifecycle management.

The role requires strong technical documentation skills, regulator-ready communication, and cross-functional collaboration to ensure commercial readiness and

Qualifications

• BS degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related field with minimum 14 years of experience; Master’s with 10 years; PhD with 7 years.
• Demonstrated late-stage development and commercialization experience including process characterization, PPQ, validation, and commercial readiness.
• Demonstrated experience independently authoring CMC sections for a BLA, MAA, or comparable marketing application.

Responsibilities

• Lead or support design, execution, analysis, and documentation of process characterization and validation studies for viral vector manufacturing processes.
• Provide technical support for upstream, downstream, formulation, fill-finish, and related manufacturing operations.
• Author and coordinate CMC sections for BLAs, MAAs, and other global marketing applications with emphasis on viral vector manufacturing and process controls.
• Translate complex data into regulator-ready narratives, tables, and responses.
• Lead or support responses to Health Authority questions and information requests.

Job description

AstraZeneca in Gaithersburg, MD seeks an experienced Principal Process Engineer to lead late-phase process development, characterization, and PPQ readiness for viral vector manufacturing. This individual will provide technical leadership across internal and external sites, with a focus on regulatory submissions and lifecycle management.

The role requires strong technical documentation skills, regulator-ready communication, and cross-functional collaboration to ensure commercial readiness and