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.

• 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.

• 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.

• 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…