Scientist I, Parenteral Drug Product Development

Role: Scientist I/II in Parenteral Formulation and Drug Product Development, supporting the formulation and process development of sterile parenteral drugs for preclinical, clinical, and potentially commercial stages. Responsibilities include designing and executing formulation studies, optimizing manufacturing processes, supporting GMP campaigns, and contributing to regulatory documentation. The role involves collaboration across R&D, manufacturing, quality, and regulatory teams, with an emphasis on drug delivery systems, container closure, and manufacturing equipment. Qualifications: Ph.D. (0-4 years), M.S. (2-4+ years), or B.S. (4-6+ years) in Chemical Engineering, Pharmaceutics, Analytical Chemistry, or related fields. Skills include hands-on experience with sterile drug formulations, process validation, analytical characterization, and regulatory documentation, with preferred experience in biologics, high-concentration protein formulations, and technology transfer. HighValue: sterile parenteral drug development, preclinical/clinical support, GMP manufacturing, regulatory documentation (IND/CMC). Work setup: likely hybrid or onsite; specific travel not stated.