AstraZeneca
Principle Process Engineer, Viral Vector Process Characterization and Commercialization
US - Gaithersburg - MD · Senior
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$22,517 more — $144,830 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $144,830 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Materials Engineers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Materials Engineers (17-2131) · Washington-Arlington-Alexandria, DC-VA-MD-WV. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- 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.
- Apply process knowledge and data analysis to identify technical risks, investigate process performance issues, and recommend practical solutions.
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.
- Ensure consistency of process descriptions, terminology, acceptance criteria, and technical conclusions across submission sections and source documents.
- Support post-approval changes, comparability assessments, supplements or variations, and commercial lifecycle management submissions.
- Commercialization and Manufacturing Support
- 24-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
Requirements
- 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.
- 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.
- 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.
Nice to have
- Direct experience with viral vector manufacturing and commercialization.
- Significant authorship responsibility for an approved or filed BLA, MAA, or other global marketing application.
- 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.
- At AstraZeneca, you will have the opportunity to make a meaningful impact through science that changes lives.
- In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
Compensation
- The annual base pay (or hourly rate of compensation) for this position ranges from $ 122,312.80 - $ 183,469.20.
Benefits
- offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
- Lead or support responses to Health Authority questions and information requests related to manufacturing process, process performance, validation, comparability, and control strategy.
Equal opportunity
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.