Senior Process Engineer, Downstream Process Characterization & Commercialization

Introduction to role

Are you ready to make a significant impact in the field of viral vector programs? We are looking for a motivated Senior Process Engineer to join our team and support downstream process characterization and commercialization activities.

In this role, you'll be at the forefront of process characterization, PPQ readiness, BLA-enabling studies, and technology transfer to both internal and external manufacturing sites. Your focus will be on downstream unit operations such as clarification, chromatography, filtration, concentration, and formulation. If you have hands-on experience in downstream process development or manufacturing and possess strong technical depth, this is the opportunity for you!

NOTE: Up to 25% domestic and international travel required.

Accountabilities:

Downstream Process Characterization & Validation

• Design, implement and support process characterization studies (DOE, multivariate studies, scaling assessments) for all downstream unit operations.

• Perform data analysis, author technical reports, and present study outcomes to cross-functional teams.

• Support development and refinement of control strategies, CPP/ CQA linkages, and process validation approaches.

• Conduct batch record review, deviation evaluation, and data trending to ensure process robustness.

• Apply AI-enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding, driving faster and more consistent decision-making during late-stage development.

• PPQ, Tech Transfer & Manufacturing Readiness

• Contribute to PPQ planning, readiness, execution, and documentation for downstream processes.

• Participate in technology transfer to internal manufacturing facilities and CDMOs; support fit-for-purpose assessments and alignment on process parameters and acceptance criteria.

• Provide on-the-floor technical support during scale-up, engineering runs, PPQ batches, and commercial campaigns (including off-shift support when required).

• Support raw material assessments, process risk evaluations, and comparability studies across facilities.

Regulatory Support

• Contribute to authoring and reviewing CMC content, including:

• Process descriptions

•  Characterization summaries

•  PPQ protocols and reports

•  Comparability justifications

•  Control strategy elements

• Assist with preparation of BLA/MAA submission documents and responses to regulatory questions.

• Cross-Functional Collaboration

• Work closely with upstream, fill-finish, analytical sciences, quality, regulatory, and manufacturing partners to ensure technical alignment.

• Represent downstream characterization activities in technical meetings and governance discussions.

• Support lifecycle management, post-approval changes, and process optimization initiatives.

Essential Skills/Experience:

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field (2+ years industry experience); OR M.S. with 5+ years of experience; OR B.S. with 7+ years of hands-on industry experience.

• Experience with downstream bioprocess unit operations, preferably in viral vector.

• Experience with late-stage development, PPQ principles, and process characterization approaches.

• Demonstrated proficiency in employing AI tools and digital solutions (e.g., data extraction, document drafting, analysis, workflow automation) to enhance efficiency and accuracy, with the ability to quickly adopt and integrate new AI technologies into daily work.

• Practical experience with GMP environments, batch record execution or review, deviations, and investigations.

• Strong technical writing skills and experience with structured data analysis.

• Desirable Skills/Experience

• Experience supporting late-stage viral vector programs (lentiviral, AAV, adenoviral, VLPs, etc.).

• Experience with DOE design and execution, and multivariate data analysis tools.

• Experience supporting BLA/MAA filings or contributing to CMC sections.

• Knowledge of control strategy development and risk assessment tools (e.g., FMEA).

• Formal training or certification in AI, digital analytics, or automation tools, demonstrating the ability to apply current digital solutions to process development, data analysis, and documentation workflow.

The annual base pay for this position ranges from $103,286.40 - $154,929.60. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally, working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way, we offer opportunities for growth and development in a supportive environment.

Join us in making a difference—apply today!

Date Posted

09-Dec-2025

Closing Date

25-Dec-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.