Process Development Engineer I, Purification - Viral Clearance

Regeneron is seeking a Process Development Engineer I as a full-time position to work in the Purification Development group within Pre-Clinical Manufacturing and Process Development (PMPD). In this exciting role you will be primarily involved in the design and implementation of viral clearance studies to demonstrate virus safety of biotechnology products throughout the product development cycle from Phase I clinical trials through commercial licensure.

A Typical Day in The Role Might Look Like:

• Design and leads multiple viral clearance projects with supervision

• Develops and qualifies scale-down models for viral inactivation, chromatography and membrane filtration unit operations

• Travels to external laboratories (20 – 25%) to execute viral clearance studies in accordance with GLP

• Collaborates with cross-functional groups to coordinate study logistics

• Summarizes studies and results in electronic laboratory notebooks, technical reports, and regulatory filings

• Presents work at group and department meetings

• Reviews protocols, reports, risk assessments and other technical documents

• Maintains and troubleshoots equipment and instrumental/experimental problems

• Stays current with the latest scientific and engineering developments in the field by reading the current literature and attending seminars and conferences

This Role Might Be For You If You:

• Contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.

• Anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and take on problems.

• Keep up with SOP training and/or compliance responsibilities.

The role requires a Bachelor’s and/or Master’s degree in either Chemical Engineering, Biochemical Engineering, or Biochemistry, and 3+ w/BS and 0-3 years’ experience w/MS in the biotech or pharmaceutical industry. A strong fundamental understanding of various protein purification techniques is a plus. Experience with Downstream Development and with equipment like: Akta Explorer/Avant, Akta Pilot, BioProcess Skid, Disc Stack Centrifuge, Depth filtration, Tangential flow filters, Normal flow filters, Chromatographic columns, HPLC, UPLC, Diafiltration skid, Raman Spectroscopy, Laminar Flow Hood, Chemical Fume hood, Empower, Unicorn, PI Historian, JMP, LIMS, Spotfire, RPES, ELN.

#pmpd

Intro To PMPD Video:

https://www.youtube.com/watchv=pAboGKlI1zw&list=PL_7lj13Lp4fH4OssUue8J5bby6muZsaR4&index=5

Intro To PMPD Purification Video:

https://www.youtube.com/watchv=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 Cana