Regeneron→
Sr. Scientist, Drug Product Development at Regeneron in Tarrytown, NY
Skills
Job Description
Regeneron is seeking a highly skilled and motivated Senior Scientist to join Drug Product Development (DPDT) Group. This Sr. Scientist position offers an exciting opportunity to work on various aspects of Drug Product development including high throughput formulation screening, characterization & development, lyophilization & other drug product process development activities for biologics, including monoclonal antibody (mAb), peptides, fusion proteins etc.
A Typical Day In The Role Might Look Like:
Lead design and execution of high-throughput (HT) formulation studies to rapidly screen excipients for desirable physicochemical characteristics and stability for mAbs, peptides and fusion proteins etc. Perform HT analytical characterization and leverage statistical tools (e.g., JMP) to process large data sets efficiently.
Lead development and optimization of lyophilization cycles for various modalities across different phases of development
Perform biophysical and biochemical characterization of liquid and lyophilized formulations using techniques such as DSC, FDM, TGA, SE-UPLC, and others.
Support and lead process development, scale-up, technology transfer, and troubleshooting activities with Contract Manufacturing Organizations (CMOs) in collaboration with Industrial Operations & Product Supply (IOPS).
Collaborate cross-functionally with colleagues from Product, Analytical & Preclinical Development (PAPD) and IOPS organizations to advance the program needs.
Participate and contribute in cross-functional meetings to provide technical expertise and contribute to project planning and decision-making. Communicate effectively with stakeholders to ensure timely delivery of project milestones and objectives.
Draft and review protocols, technical reports, and supporting documents towards regulatory filings.
Stay abreast of advancements in DP Development technologies including novel process tools, HT methodologies, analytical tools and industry trends to drive innovation within the group.
Identify and implement process improvements to enhance efficiency, scalability, and quality in lyophilization and formulation development.
This Role Might Be for You If You Have:
Strong problem-solving skills and ability to address technical challenges in a fast-paced environment.
Ability to work independently and in team settings to drive the challenging task efficiently
Excellent technical writing, communication, and project management skills. Demonstrated ability to collaborate cross-functionally.
This position requires a Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical and Biomolecular Engineering, or a related field with 0 - 3 years of relevant industry experience; OR M.S. with 8+ years of experience. Experience working with monoclonal antibodies and peptides is highly desirable with hands-on experience with biochemical and biophysical techniques for protein characterization using chromatography (SE-UPLC, IEX, RP-UPLC), electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), UV-Vis, Viscosity and thermostability characterization (DSC, DSF). Expertise in lyophilization process development, including design, execution, and troubleshooting is desired as well. Experience with statistical software (e.g., JMP) for design of experiments and data analysis preferred. Ability to build efficient workflows for formulation screening and analytical testing and experience with automation tools is a plus.
This is a unique opportunity to contribute to cutting-edge drug product development initiatives and work on innovative technologies that will shape the future of the organization. You will join a dynamic and collaborative team committed to excellence and innovation in pharmaceutical development.
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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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)