Sr Scientist, Formulations (Drug Product Development)

Role Summary

Senior Scientist, Formulation Development – Drug Product Group. Focused on high-throughput formulation screening, characterization and development, lyophilization, and other drug product process development activities for biologics, including monoclonal antibodies, peptides, and fusion proteins.

Responsibilities

• Lead design and execution of high-throughput formulation studies to screen excipients for desirable physicochemical characteristics and stability for mAbs, peptides, and fusion proteins; perform HT analytical characterization and use statistical tools to process large data sets.
• Support and lead process development, scale-up, technology transfer, and troubleshooting activities with Contract Manufacturing Organizations (CMOs) in collaboration with Industrial Operation & Process Sciences (IOPS).
• Lead development and optimization of lyophilization cycles for various modalities across development phases.
• Perform biophysical and biochemical characterization of liquid and lyophilized formulations using techniques such as DSC, FDM, TGA, SE-UPLC, and others.
• Collaborate cross-functionally with Product, Analytical & Preclinical Development (PAPD), and IOPS to advance program needs.
• Participate in cross-functional meetings to provide technical expertise and contribute to project planning and decision-making; communicate with stakeholders to ensure timely delivery of milestones.
• Draft and review protocols, technical reports, and supporting documents for regulatory filings.
• Stay abreast of DP Development technologies 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.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related field with 0–3 years of relevant industry experience; OR M.S. with 10+ years of experience.
• Experience with monoclonal antibodies and peptides; 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.
• 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; experience with automation tools is a plus.

Skills

• Strong problem-solving skills in a fast-paced environment
• Independent work style with ability to collaborate in a team
• Technical writing, communication, and project management skills; cross-functional collaboration

Education

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field (or an M.S. with substantial industry experience as stated above)