Senior / Principal Chemist - Synthetic Chemistry and API ManufacturingDescriptionThe 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 FunctionsChemistry 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.
QualificationsWe 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 - $125,000The salary range is intended as a general guideline and is not a guaranteed offer, as compensation depends on various factors such as scope and responsibilities of the position, candidate qualifications, experience, internal equity, and market conditions. MRIGlobal also provides a comprehensive benefits package, including health and life insurance, disability coverage, gym reimbursement, mental health support, paid holidays, and PTO.
WHAT WE OFFERAt MRIGlobal, we offer benefits and perks that make your life even better.
Your Well-Being: You can receive comprehensive coverage for you and your family, and resources that support mental, physical, social, and financial well-being. Get access to wellness benefits like virtual coaching, no-cost counseling, onsite health screenings, gym reimbursement, and more. MRIGlobal has received multiple wellness recognitions, including being named "Healthiest Employer" by Kansas City's Business Journal in 2024.
A Bright Future: MRIGlobal offers award-winning employer retirement matches and no-cost financial education benefits. Get paid Parental Leave. Enjoy 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. Join our seasonal staff events, DEI celebrations, and volunteer in initiatives that nurture future STEM generations.
To view all of MRIGlobal's current openings and to ensure that we receive your resume, visit our Career page.
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