Tarrytown, NY, 10591, USA
16 hours ago
Process Development Engineer I - Synthetic and Bioconjugation Scale Up Technologies
Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer I for its Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work with cross-functional teams for process development and optimization using the principles of Quality by Design (QbD) to make the processes suitable for GMP production. This role also involves process scale-up and technology transfer to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization. **A Typical Day in the Role of Process Development Engineer I Might Include:** + Working at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes. + Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization techniques. + Discussing plans and data in cross functional teams to evaluate processes and determine developmental goals and ensure integrated program success. + Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc. + Using statistical design of experiments (DOE) to optimize bioconjugation processes including conjugation reactions, purification operations, and analytical characterization. + Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMO’s intended for GMP production and successfully transferring processes with immediate, first-time success. **This Role May be for You if You:** + Enjoy working in the lab to advance exciting new drug modalities to patients. + Have strong initiative and aim to complete challenging tasks and learn new technologies. + Are capable of multi-tasking and working both independently and in a collaborative environment involving cross-functional teams. This role requires a Bachelor’s 3+ years proven experience or Master’s in chemical/biochemical engineering or a related field. Experience with antibodies in the bioconjugates space is highly preferable. Hands on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, membrane technologies etc. is preferred. Experience with a variety of analytical characterization tools such as mass spectrometry, high-performance liquid chromatography (HPLC), UV spectroscopy, etc. is preferred. **Note: title will be commensurate with experience** **\#pmpd** **Intro To PMPD Video:** https://www.youtube.com/watch?v=pAboGKlI1zw&list=PL\_7lj13Lp4fH4OssUue8J5bby6muZsaR4&index=5 **Intro To PMPD Purification Video:** https://www.youtube.com/watch?v=aZ82TmphmfA&list=PL\_7lj13Lp4fH4OssUue8J5bby6muZsaR4&index=6 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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)** $79,100.00 - $129,100.00
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