Senior Viral Vector Process Engineer – PPQ & CMC Lead

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

Job summary

AstraZeneca is seeking an experienced Principal Process Engineer to lead late-phase process development, characterization, validation, and commercialization of viral vector manufacturing. This individual will provide hands-on technical leadership across internal and external sites, focusing on PPQ readiness and regulatory submissions.

The role requires independent authorship of CMC content for BLAs/MAAs and close collaboration with Drug Substance, Drug Product, Analytical Sciences, Quality,

Qualifications

• BS in Chemical Engineering with significant biopharmaceutical process development experience or MS/PhD with extended relevant expertise.
• Experience in late-stage development, PPQ, validation, and commercial readiness for biologics.
• Ability to author regulatory CMC sections independently and coordinate with cross-functional teams.

Responsibilities

• Lead or support design, execution, analysis, and documentation of process characterization and validation for viral vector manufacturing.
• Provide technical support for upstream, downstream, formulation, fill‑finish operations.
• Develop risk-based approaches for process parameters and control strategies.
• Lead PPQ planning, protocol development, data review, and final report authoring.
• Translate technical data into regulator-ready narratives and ensure consistency across submissions.

Skills

Process engineering

Biopharmaceuticals

Regulatory writing

Cross-functional collaboration

GMP knowledge

Education

BS in Chemical Engineering

MS in relevant field

PhD (optional)

Tools

CTD/CMC documentation

Regulatory submissions

Job description

AstraZeneca is seeking an experienced Principal Process Engineer to lead late-phase process development, characterization, validation, and commercialization of viral vector manufacturing. This individual will provide hands-on technical leadership across internal and external sites, focusing on PPQ readiness and regulatory submissions.

The role requires independent authorship of CMC content for BLAs/MAAs and close collaboration with Drug Substance, Drug Product, Analytical Sciences, Quality,