Principle Process Engineer, Viral Vector Process Characterization and Commercialization
AstraZeneca
Summary
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.
Job description
Key Responsibilities
Late-Phase Process Development and Validation
- 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.
Regulatory CMC Authoring and Marketing Applications
- 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.
Commercialization and Manufacturing Support
- 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.
Cross-Functional Collaboration
- 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.
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
Benefits
- 401(k) Matching
- Paid Time Off
- Medical, Dental & Vision
- Short-term Incentive Bonuses
- Equity-based Awards
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.