Principal Chemist - IPS-Synthesis & API Mfg

Senior / Principal Chemist – Synthetic Chemistry and API Manufacturing Description The Senior / Principal Chemist is a hands-on, senior technical contributor within the synthetic chemistry and API manufacturing group. The primary focus of this role is the day-to-day execution of small molecule chemistry. Responsibilities include route and process development, optimization, and current Good Manufacturing Practice (cGMP) manufacturing in support of early-phase clinical API production. As part of a highly collaborative and integrated team, the successful candidate will contribute across all aspects of small molecule synthesis, from laboratory development through cGMP batch execution, in compliance with 21 CFR Parts 210 and 211. The role works closely with analytical development and quality assurance to deliver high-quality drug substance for early-phase clinical studies. This is an individual-contributor role with a clear path to grow into a technical leadership position for the right candidate. Essential Functions Chemistry Execution (Primary) Perform hands-on synthesis of small molecule APIs and intermediates at laboratory scale (milligram to multi-gram quantities). Draft, review, and execute cGMP manufacturing batch records for drug substance under cGMP conditions, while supporting non-cGMP laboratory operations as needed. Carry out route scouting, process development, and optimization to define safe, scalable, and reproducible processes. Support scale-up and technical transfer of API processes from the laboratory to early-phase manufacturing scale (multi-kilogram quantities). Characterize intermediates and products and interpret data from analytical techniques such as IR, MS, NMR, and U/HPLC, in coordination with analytical development. Maintain accurate, contemporaneous documentation, including laboratory records, protocols, and batch records. Contribute to technical problem-solving and risk mitigation in support of client-sponsored programs, including participation in technical discussions and data reviews. Technical Contribution Apply solid organic synthesis fundamentals and process chemistry expertise to solve technically complex and ambiguous problems. Apply phase-appropriate cGMP and FDA guidance, including 21 CFR 210/211, ICH Q7, ICH Q11, and other relevant ICH guidelines, as well as pharmacopeial standards (USP, EP). Contribute to Chemistry, Manufacturing, and Controls (CMC) documentation supporting Investigational New Drug (IND) filings. Apply DOE and QbD approaches to develop robust API processes, where appropriate. Laboratory Operations & Growth Take ownership of assigned equipment and instrumentation, including routine maintenance, qualification support, and safe operation. Support laboratory cGMP compliance, safety practices, and a clean, well-organized work environment. Provide informal technical guidance and mentorship to junior staff as appropriate. Over time, take on task lead responsibilities and grow toward a broader technical leadership role. Success Factors Strong hands-on expertise in synthetic organic chemistry and process chemistry. High attention to detail, especially in documentation. Sound technical judgment and the ability to troubleshoot and make decisions with incomplete information. Familiarity with cGMP drug substance manufacturing and FDA requirements (desired). Ability to draft and follow protocols, SOPs, test plans, and batch records. Effective written and oral communication, including the ability to convey technical detail to non-specialists and clients. Ability to thrive in a fast-paced, dynamic team environment where breadth and flexibility are essential. Aptitude and interest in growing into a technical leadership role. Qualifications We welcome applicants across a range of education and experience levels. Representative paths include: PhD in Chemistry, Pharmaceutical Sciences, or a related field with 4+ years of relevant experience; or MS in a related field with approximately 7+ years…