Process Development Engineer II

Regeneron Pharmaceuticals • Tarrytown, GA

18h • Onsite

About The Position

Regeneron’s Cell Culture Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Engineer II 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 to conduct cell line selection, perform medium and feed development, and define optimal and robust upstream processes in support of clinical or commercial manufacturing production. A Typical Day in the Role of Process Development Engineer II Might Look Like: Conducting statistical data analysis and leveraging Quality by Design (QbD) framework to define commercial processes for biologics Coaching and mentoring developers in a matrixed environment Designing and executing cell culture studies in single-use bioreactors (including AMBR250 system), and glass bench scale bioreactors (2L to 15L scale) Operating and maintaining bioreactor and analytical equipment, preparing media and feed, generating cell banks Generating, analyzing, and managing critical data in a highly organized manner Coordinating and collaborating with colleagues from other groups involved in the research process, including cell line development, bioreactor scale-up, purification, analytics, and manufacturing. Authoring technical documents, 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 This Job May Be For You If: You have exception written and oral communication skills, with the ability to effectively engage and collaborate with stakeholders at all levels within a matrixed organization, including technical teams, management, and external vendors. You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, direct projects, and mentor developers. You have strong initiative to complete ambitious projects and drive new technology implementation. You have experience in development of cell culture processes, experimental design, statistical analysis of data, and process characterization experience for commercial-enabling processes. You have proven experience working independently and within a team environment on multiple projects simultaneously in an R&D laboratory setting.

Requirements

• You have exception written and oral communication skills, with the ability to effectively engage and collaborate with stakeholders at all levels within a matrixed organization, including technical teams, management, and external vendors.
• You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, direct projects, and mentor developers.
• You have strong initiative to complete ambitious projects and drive new technology implementation.
• You have experience in development of cell culture processes, experimental design, statistical analysis of data, and process characterization experience for commercial-enabling processes.
• You have proven experience working independently and within a team environment on multiple projects simultaneously in an R&D laboratory setting.
• This role requires a Master’s degree in Chemical Engineering or Bio-related Engineering with 3-6 years, or a Bachelor’s degree (6+ years) of experience in a laboratory setting.

Nice To Haves

• Experience with mammalian cell culture; developing fed-batch bioreactor commercial processes including leveraging Quality by Design (QbD) framework; statistical design and analysis software (i.e., JMP).
• Experience with technology transfer to manufacturing facilities and providing person-in-plant support and troubleshooting for upstream commercial processes.
• Demonstrated leadership abilities, prior mentorship experience, and a track record of successfully managing cross-functional projects and/or teams.

Responsibilities

• Conducting statistical data analysis and leveraging Quality by Design (QbD) framework to define commercial processes for biologics
• Coaching and mentoring developers in a matrixed environment
• Designing and executing cell culture studies in single-use bioreactors (including AMBR250 system), and glass bench scale bioreactors (2L to 15L scale)
• Operating and maintaining bioreactor and analytical equipment, preparing media and feed, generating cell banks
• Generating, analyzing, and managing critical data in a highly organized manner
• Coordinating and collaborating with colleagues from other groups involved in the research process, including cell line development, bioreactor scale-up, purification, analytics, and manufacturing.
• Authoring technical documents, 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

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level