Process Engineer, Upstream Process Characterization & Commercialization

We are seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. In this role, you will contribute to late‑stage development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to internal and external manufacturing sites.

This position focuses specifically on upstream unit operations, including shake flask and bioreactor‑based cell culture, transient transfection, cell expansion, harvest operations, and scale‑up across development and commercial platforms (including Amber systems).

The ideal candidate has strong hands‑on experience in upstream viral vector manufacturing, transient transfection‑based processes, and can provide on‑the‑floor technical leadership during engineering, PPQ, and commercial campaigns.

• Design, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments).
• Develop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations.
• Perform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums.
• Support development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters.
• Conduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes.
• Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.

• Contribute to PPQ planning, readiness, execution, and documentation for upstream processes.
• Support technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation.
• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
• Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.

• Contribute to authoring and review of CMC documentation, including upstream process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
• Support preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing.

• Work closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
• Represent upstream characterization activities in technical meetings, reviews, and governance discussions.
• Support lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes.

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience.
• Hands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes.
• Experience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred.
• Experience with late‑stage development, process characterization, and PPQ principles for upstream processes.
• Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
• Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
• Strong technical writing, data analysis, and problem‑solving skills.

• Experience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs).
• Experience designing and executing DOE and multivariate data analysis for upstream processes.
• Experience contributing to BLA/MAA submissions or regulatory…