Senior Scientist, Formulation and DP Development

Responsibilities

• Participate in formulation and DP development for phase-appropriate liquid and lyophilized formulations for intermediates, drug substance, and drug products.
• Engage in technology transfer activities to Contract Manufacturing Organizations (CMOs).
• Design, execute, and document formulation, stability, and in-use/compatibility studies to support final formulation, clinical administration, and manufacturing processes.
• Utilize/implement fit-for-purpose analytical methods for biophysical characterization, formulation, and process development, and stability testing.
• Communicate experimental data through verbal presentations and written documents, including those required for regulatory filings.

Qualifications

• BS/MS (12+ years) or PhD (7+ years) in a scientific discipline (Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or related field).
• Demonstrated scientific creativity and contributions.
• Strong technical skills and experience in pre-formulation screening studies, biophysical/ biochemical characterization of proteins, analytical method development, and protein/ antibody/ADC product development.
• Practical experience with design and execution of in-use stability studies for biologics and compatibility with administration components.
• Demonstrated ability to design experiments and generate new ideas and original research.
• High level of scientific initiative and independence; highly autonomous with minimal supervision.
• Experience with analytical instrumentation such as chromatographic (HPLC, UPLC, column chromatography), visible and subvisible particle analysis, capillary electrophoresis, and/or biophysical techniques (UV-vis, MALS/DLS, DSC, CD, FTIR, AUC, Fluorescence spectroscopy) for protein characterization.
• Effective cooperation with cross-functional teams, including upstream and downstream process development, manufacturing, and quality.
• Ability to adapt to changes in project direction and work on multiple projects simultaneously in a fast-paced environment.
• Excellent oral and written communication skills and attention to detail.