Principal Chemist - IPS-Synthesis & API Mfg

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.

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.
• 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.
• Solid 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.
• Able 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;
  • MS in a related field with approximately 7+ years of relevant experience;
  • 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

Benefits

• Comprehensive benefits package, including health and life insurance, disability coverage, gym reimbursement, mental health support, paid holidays, and PTO.
• Awards for employer retirement matches and no-cost financial education benefits.
• Paid Parental Leave.
• PTO, and a flexible culture that encourages work-life integration.
• Personal Development: At MRIGlobal, you will enjoy diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• A Genuine Community: MRIGlobal is a special workplace. From our Chili Cook-offs, Pi Day, and charitable giving opportunities, our traditions strengthen our team spirit.
• Seasonal staff events, DEI celebrations, and volunteer in initiatives that nurture future STEM generations.