Sr. Scientist, Drug Product Development

About the role

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.

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• Strong problem-solving skills and ability to address technical challenges in a fast-paced environment.
• Excellent technical writing, communication, and project management skills.
• Demonstrated ability to collaborate cross-functionally.

Skills

• Strong problem-solving skills and ability to address technical challenges in a fast-paced environment.
• Excellent technical writing, communication, and project management skills.
• Demonstrated ability to collaborate cross-functionally.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$109,900.00 - $179,300.00 annually

Schedule

Full-time