Sr. Scientist, Drug Product Process Development (Formulations) at Regeneron Pharmaceuticals, Inc.

We are seeking a highly motivated Sr. Scientist to join the Process Development (PD) team within the Formulations Development Group (FDG) at Regeneron Pharmaceuticals Inc. in Tarrytown, NY. You will plan and drive Drug Product (DP) process development activities across our genetic medicines and biologics pipeline. Responsibilities include supporting risk assessments, technology transfer to manufacturing sites, developing scaled-down models, and setting up in-house drug product process development capabilities.

• Lead DP process development activities and independently design, performed, analyzed, and document experimental studies using at-scale and/or scaled-down models needed for the characterization of the different unit operations for the manufacturing of DP in vials or syringes (freezing/thawing, compounding, mixing, filtration, filling, and lyophilization).
• Support preclinical activities including toxicological filling campaigns.
• Support setup of in-house DP process development capabilities in FDG. Responsibilities include supporting pilot labs management, updating and optimizing inventory, procuring tools and equipment, coordinating small scale and manufacturing scale equipment installation and operation, and working closely with key members of formulation development, manufacturing and Facility & EHS management teams to ensure full functionality of drug product pilot labs.
• Ensure strong strategic partnerships & communication with colleagues from Research Groups, Drug Product & Drug Substance Manufacturing (internal and external partners, CMOs), Project Management, Regulatory Sciences, and Quality.
• Routinely author and review guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites.

• The ability to work effectively in a team environment and capacity to quickly adapt to changes in project direction.
• A consistent record of publications with creative, productive, and insightful statistical-based analysis.
• Excellent oral/written communication skills and interpersonal skills to support frequent interactions with collaborators.

Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical or Biomedical Engineering (or related subject area) with 0-3 years of relevant industry working experience. Experience with biologics drug product (formulation and process) development and characterization is helpful. Possesses strong capability with analytical instruments in characterizing protein therapeutics. Proven skills & understanding in support of GMP manufacturing, quality and regulatory functions is a plus. Hands-on experience and know-how of DP process related unit operations is a plus. Experience in developing and implementing small scale models is helpful. A proven record of publications with innovative experimental designs and insightful statistical analyses is desired.

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)