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, including route and process development, optimization, and cGMP manufacturing to support early‑phase clinical API production. Working closely with analytical development and quality assurance, the candidate will deliver high‑quality drug substance and has a clear path to future technical leadership. 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 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 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 of relevant experience; or BS in a related field with approximately 10+ years of relevant experience. Required: Demonstrated hands‑on experience in synthetic organic chemistry. Strongly desired: Experience in process chemistry, API process development, and cGMP drug substance manufacturing. Pay Range $117,000 – $125,000. The salary range is a general guideline; compensation depends on scope and responsibilities, qualifications, experience, internal equity, and market conditions. Benefits Health, life, and disability insurance; gym reimbursement; mental health support; paid holidays and PTO. Retirement match and financial education benefits; Parental leave; flexible work culture. Tuition reimbursement for higher education. Well‑being resources such as virtual coaching, onsite health screenings, and wellness programs. EEO Statement Equal Opportunity Employer, including disability/veteran status. MRIGlobal invites and embraces diversity, fostering a safe, inclusive environment where all perspectives are valued. Vaccination Requirement Roles that require specific safety measures may require up‑to‑date vaccinations. Proof of vaccination is required prior to start. Individuals unable to meet the requirement due to medical condition, disability, pregnancy, or religious belief may request a reasonable accommodation. Contact View email address on click.appcast.io for accommodations. #J-18808-Ljbffr MRIGLOBAL