Senior Process Engineer, Downstream Process Characterization & Commercialization

Role Summary

Senior Process Engineer for Downstream Process Characterization & Commercialization. Responsible for downstream process characterization and technology transfer activities to support PPQ readiness and BLA-enabling studies in viral vector programs. Focus areas include downstream unit operations such as clarification, chromatography, filtration, concentration, and formulation, with hands-on experience in downstream process development or manufacturing.

Responsibilities

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

Qualifications

• Required: 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.
• Proficiency in employing AI tools and digital solutions to enhance efficiency and accuracy, with 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.

• Preferred: 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 ability to apply current digital solutions to process development, data analysis, and documentation workflow.

Skills

• AI, digital analytics, and automation proficiency; data extraction, drafting, analysis, and workflow automation.
• Strong technical writing and data analysis capabilities.
• GMP knowledge and experience with batch records, deviations, and investigations.
• Cross-functional collaboration and effective communication in technical settings.

Education

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field (or equivalent industry experience).
• Alternative: M.S. with substantial relevant experience; B.S. with extensive hands-on industry background as defined above.

Additional Requirements

• Up to 25% travel (domestic and international) required.