Process Development Associate (PMPD) - Late Stage Cell Culture

Role Summary

Regeneron’s Cell Culture Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late stage development team to develop production processes of monoclonal antibodies in a non-GMP process development laboratory. In this role, they will perform studies at bench scale in support of clinical or commercial manufacturing production.

Responsibilities

• Designing and developing cell culture studies in shaker flasks, single-use bioreactors (including AMBR250 system), and glass bench scale bioreactors (2L to 15L scale)
• Preparing media, feed, buffers, and reagents
• Operating and maintaining bioreactor and analytical equipment
• Conducting statistical data analysis
• Generating, managing, analyzing, and maintaining critical data in a highly organized manner
• Coordinating and working with colleagues from other groups involved in the research process, including cell line development, bioreactor scale-up, purification, analytics, and manufacturing
• Authoring development reports, entering electronic lab notebook entries, and reviewing manufacturing records
• Active involvement in technology transfer via written process transmittals, and by providing troubleshooting, process understanding, and on-site support to manufacturing production campaigns in Albany, NY
• The position requires work on weekends and occasional travel to upstate NY

Qualifications

• Required: BS or MS in Chemical Engineering or Bio-related Engineering with 0-2 years of experience in a laboratory setting
• Excellent verbal and written communication skills, and record keeping abilities to accurately record, analyze, and document development data generated
• Preferred: Experience with mammalian cell culture; experience with developing fed-batch bioreactor processes including optimizing feeding strategies and evaluating different cell culture media and feed formulations; experience with AMBR250; and experience with statistical design and analysis software (e.g., JMP)

Skills

• Strong initiative and drive to complete ambitious tasks and learn new technologies
• Ability to work independently and in a team on multiple projects simultaneously
• Contributions to lab equipment maintenance and safety to support a safe, effective, and efficient working environment
• Strong organizational, communication, analytical, computer, and technical writing skills

Education

• BS or MS in Chemical Engineering or Bio-related Engineering

Additional Requirements

• On-site work may be required; travel to upstate NY as part of manufacturing campaigns