Senior Pharmaceutical Development Scientist

Our client, a leading pharmaceutical company dedicated to advancing human health through innovative drug discovery and development, is seeking a highly skilled Senior Pharmaceutical Development Scientist to join their research and development team in Chicago, Illinois . This critical role will focus on the development of novel drug formulations and manufacturing processes for both small molecule and biologic drug candidates. The Senior Scientist will lead projects, conduct formulation studies, optimize manufacturing processes, and contribute to the scale-up and technology transfer of new drug products. You will collaborate closely with discovery research, clinical development, and regulatory affairs teams to ensure the successful progression of drug candidates from preclinical to clinical stages. This position requires a deep understanding of pharmaceutical sciences, formulation development, and process chemistry. The ideal candidate possesses strong analytical skills, excellent problem-solving abilities, and a proven track record in pharmaceutical development. We are looking for an experienced scientist who is passionate about bringing life-changing medicines to patients.

Key responsibilities include:

Designing and executing studies for the formulation development of small molecules and biologics. Optimizing drug delivery systems and exploring novel excipients to enhance drug efficacy and stability. Developing and validating analytical methods for characterization of drug substances and drug products. Investigating and resolving formulation and manufacturing process challenges. Leading process development activities and scale-up efforts for manufacturing clinical trial materials. Collaborating with contract manufacturing organizations (CMOs) for process transfer and validation. Preparing comprehensive development reports, technical documentation, and regulatory submission data. Staying abreast of the latest scientific advancements and regulatory guidelines in pharmaceutical development. Mentoring junior scientists and providing technical guidance on formulation and process development. Contributing to the intellectual property portfolio through invention disclosures. Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant quality standards.

The ideal candidate will possess a Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline. A minimum of 7 years of hands-on experience in pharmaceutical formulation development and process R&D is required. Demonstrated expertise in various dosage forms (e.g., oral solids, injectables) and characterization techniques is essential. Strong knowledge of GMP, regulatory requirements (FDA, EMA), and drug development lifecycle is a must. Excellent written and verbal communication skills are necessary for technical reporting and cross-functional collaboration. The ability to lead projects independently and contribute effectively within a team in our Chicago, Illinois facility is crucial. This is an exciting opportunity to make a significant impact in the development of new medicines.