Sr. Scientist - Drug Product Process Development

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 execute DP process development activities, developing cross-scale models, supporting risk assessments and technology transfer to manufacturing sites. Responsibilities include supporting risk assessments, technology transfer to manufacturing sites, developing scaled-down models, and setting up in-house drug product process development capabilities.

A Typical Day in the Role of Scientist Might Look Like:

• Leads DP process development activities for different unit operations across multiple programs.
• Supporting implementation of cross-scale models to successfully bridge the gap between lab and manufacturing while supporting the increasing pipeline of new modalities.
• Ensures effective characterization of different unit operations for a seamless technology transfer to the manufacturing sites.
• Supports setup of in-house drug product (DP) process development capabilities in Formulations Development Group. Responsibilities include supporting laboratory layout and setup, procuring tools and equipment, overseeing equipment installation and operation, and working closely with key members of formulation development, manufacturing and facility management teams to develop full functionality of DP process laboratory.
• Independently designs, executes and documents formulation, fill and finish development studies to understand impact of process parameters on product quality attributes.
• Writes complete internal and/or external "publications" that require minimal revisions (i.e., peer reviewed publications, patents, business plans)
• Routinely authors and reviews guidelines, protocols and reports, regulatory sections, and risk assessments to support technology transfer to manufacturing sites.
• Presents work at group, department and cross functional meetings, and contributes as a process lead in drug development team meetings.
• Seeks out, recognizes and assesses existing and new technologies to improve process development capabilities in Formulations Development Group. Contributes as a knowledgeable resource on prevalent manufacturing related technologies and processes.

This Role Might Be For You If You Possess:

• 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