Principle Process Engineer, Viral Vector Process Characterization and Commercialization

AstraZeneca•Gaithersburg, MD

5d•$122,313 - $183,469•Onsite

About The Position

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.

Requirements

BS degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline with a minimum of 14 years of relevant experience in biopharmaceutical process development, manufacturing, validation, or commercialization; Master’s degree in a relevant discipline with a minimum of 10 years of experience: PhD with a minimum of 7 years of experience.
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. Experience authoring multiple regulatory sections and responding to Health Authority questions is required.
Strong understanding of Biologics manufacturing platforms, including upstream production, downstream purification, formulation, and fill-finish operations.
Working knowledge of GMP manufacturing, process validation principles, risk management, comparability, control strategy, and lifecycle management.
Ability to interpret complex technical data and convert it into concise, consistent, and regulator-ready documentation.
Excellent written and verbal communication skills, with demonstrated ability to work effectively across functions, sites, and external partners.

Nice To Haves

Direct experience with viral vector manufacturing and commercialization.
Significant authorship responsibility for an approved or filed BLA, MAA, or other global marketing application.
Experience supporting Health Authority interactions, regulatory responses, pre-approval inspections, or commercialization readiness assessments.
Experience working with CMOs or CDMOs and supporting multi-site technology transfer and PPQ programs.
Familiarity with analytical method integration, raw material and cell bank control strategies, continued process verification, and post-approval change management.
Demonstrated ability to influence cross-functional teams and deliver complex technical work with limited supervision.

Responsibilities

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 performance, validation, comparability, and control strategy.
Support post-approval changes, comparability assessments, supplements or variations, and commercial lifecycle management submissions.
Partner with internal manufacturing sites and external CMOs or CDMOs to support technology transfer, engineering activities, PPQ execution, commercial readiness, and continued process verification.
Review manufacturing records, process data, deviations, change controls, investigations, and technical reports to assess product and process impact.
Provide technical input to risk assessments, FMEAs, validation plans, protocols, reports, and integrated control strategy documents.
Contribute to inspection readiness and support technical preparation for regulatory inspections and partner audits.
Collaborate with Analytical Sciences, Quality, Regulatory Affairs, Manufacturing Operations, Supply, and other technical functions to align development, validation, and filing strategies.
Represent viral vector process engineering in cross-functional project teams, governance forums, technical reviews, and risk discussions.
Communicate technical risks, recommendations, decisions, and progress clearly to project teams and senior stakeholders.
Mentor less experienced scientists and engineers and promote strong technical documentation practices, without direct people-management responsibility.