Principle Process Engineer, Viral Vector Process Characterization and Commercialization

About AstraZeneca In Gaithersburg, MD

Our Gaithersburg, Maryland campus is a global center for innovation in biologics, cell therapy, and vaccines. The site fosters a highly collaborative and cross‑functional culture that enables teams to deliver life‑changing medicines across AstraZeneca’s pipeline. With state‑of‑the‑art research, development, and manufacturing capabilities, we advance scientific excellence through collaboration, diversity, and innovation.

Our Gaithersburg, Maryland campus is a global center for innovation in biologics, cell therapy, and vaccines. The site fosters a highly collaborative and cross‑functional culture that enables teams to deliver life‑changing medicines across AstraZeneca’s pipeline. With state‑of‑the‑art research, development, and manufacturing capabilities, we advance scientific excellence through collaboration, diversity, and innovation.

AstraZeneca is seeking an experienced Principal Process Engineer to support late-phase process development, process characterization, validation, and commercialization of viral vector manufacturing processes. This individual contributor role will provide hands‑on technical leadership across internal and external manufacturing sites, with a strong focus on PPQ readiness, BLA and other global marketing applications, and post‑approval lifecycle management.

The successful candidate will have direct late‑stage development and commercialization experience and demonstrated ability to independently author high‑quality CMC content for regulatory submissions. The role will partner with Drug Substance, Drug Product, Analytical Sciences, Quality, Regulatory Affairs, Manufacturing Operations, and external CMOs or CDMOs to ensure that process knowledge, validation strategy, control strategy, and filing content are scientifically sound, consistent, and inspection ready.

• Lead or support the 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.
• Develop and maintain science‑and‑risk‑based approaches for process parameter classification, proven acceptable ranges, in‑process controls, and control strategy development.
• Support PPQ planning, protocol development, manufacturing execution, deviation assessment, data review, and final report authoring.
• Apply process knowledge and data analysis to identify technical risks, investigate process performance issues, and recommend practical solutions.

• Independently author and coordinate CMC sections for BLAs, MAAs, and other global marketing applications, with emphasis on viral vector drug substance and drug product manufacturing, process controls, process validation, and supporting lifecycle documentation.
• Author and review relevant CTD Module 3 content, including manufacturing process descriptions, control of critical steps and intermediates, process validation or evaluation, process development summaries, control strategy content, comparability assessments, and supporting technical justifications.
• Translate complex process development, characterization, validation, and manufacturing data into clear, accurate, and regulator‑ready narratives, tables, and responses.
• Ensure consistency of process descriptions, terminology, acceptance criteria, and technical conclusions across submission sections and source documents.
• Lead or support responses to Health Authority questions and information requests related to manufacturing process, process…