Sr. Scientist, Drug Product Development Full-time

Senior Scientist

Regeneron is seeking a highly skilled and motivated Senior Scientist to join our Drug Product Development and Technology (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.