Process Development Engineer I - Late Stage Purification (PMPD)

Role Summary

Regeneron’s Late-Stage Purification Development team within PMPD (Preclinical Manufacturing and Process Development) is seeking a full-time Process Development Engineer I. The role focuses on the development and transfer of harvest, affinity chromatography, and viral inactivation unit operations for recombinant proteins using Quality by Design principles.

Responsibilities

• Designs and executes experiments at both bench and pilot-scale
• Analyzes data, draws conclusions from results, and proposes next steps
• Documents results in laboratory notebook and reports
• Communicates findings to functional area and department leadership
• Acts as purification development subject matter expert during manufacturing process transfer to ensure successful completion of GMP batches
• Works cross-functionally with the process development team to enable a robust, cohesive manufacturing process
• Supports technology development and improvement activities potentially including automation of pilot-scale unit operations, improving bench-scale process models, developing workflows for compilation and analysis of historical data, investigating new raw materials, equipment, and/or techniques to advance the harvest, affinity chromatography, and viral inactivation unit operations
• Trains peers and directly or indirectly manages, mentors, and assists co-op students and interns in conducting experiments, analyzing data, and documenting results
• Contributes to lab equipment maintenance and general lab safety to help create a safe, effective, and efficient working environment

Qualifications

• Required: Bachelor’s and 0–3 years of industry experience in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field; recombinant protein purification experience (e.g., depth filtration, disc stack centrifugation, column chromatography, virus retentive filtration, ultrafiltration/diafiltration, buffer preparation) is a plus
• Preferred: Master’s degree in a related field
• Strong fundamental understanding of protein purification techniques
• Experience with Akta chromatography systems, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, Python, Ignition, and PI Historian is advantageous
• Solid understanding and practical experience in purifying monoclonal antibodies or other biopharmaceuticals
• Ability to work 50–70% of time performing lab work at bench and pilot-scale
• Excellent communication and collaboration skills; team-oriented and well organized

Skills

• Process automation (hardware, control logic, and/or HMI development)
• Laboratory techniques for harvesting, purification, and viral inactivation unit operations
• Data analysis and interpretation; documentation and reporting
• Laboratory safety and equipment maintenance

Education

• Bachelor’s degree (Chemical Engineering, Biochemical Engineering, Biochemistry, or related) required; Master’s degree preferred