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.
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.
Preferred:- 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)$93,900.00 - $153,300.00
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