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Par Health
St. Louis, MO (Pharma) - USA032
Source: Par Health careers · View original posting
From Par Health's posting. “We” and “our” refer to the employer.
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
Job Description Summary
The Staff Synthetic Chemist position within the Par Health API Development and Support organization synthesizes small molecule analytical reference standards in support of Active Pharmaceutical Ingredient (API) and Drug Product businesses. In this critical role, you will design and execute complex, multi-step organic syntheses to generate analytical reference standards, including API impurities, degradants, and metabolites.
Beyond bench execution, you will serve as the technical lead for our Reference Standards Program, collaborating closely with Analytical R&D, Quality Control, and Regulatory Affairs to ensure compliance with ICH guidelines and cGMP requirements. The ideal candidate brings deep expertise in structural elucidation, a passion for solving complex synthetic challenges, and the ability to support a wide variety of activities related to the program.
Job Description
Essential Functions
Complex Synthesis & Purification : Design, troubleshoot, and execute multi-step synthetic routes to produce small molecule reference standards (typically on gram to multigram scale) representing API impurities, degradants, and metabolic products.
Structural Elucidation : Perform advanced isolation and characterization of synthesized compounds using modern analytical techniques (NMR, LC-MS, GC-MS, IR, etc.) to confirm chemical structures.
Reference Standard Program Technical Leadership : Oversee the lifecycle of the reference standard inventory. Drive the generation, review and approval of Certificates of Analysis (CoAs) and manage requalification schedules in alignment with regulatory standards.
Cross-Functional Collaboration: Partner with process chemistry team to identify potential process impurities and with analytical chemistry team / QC to develop specifications and test methods for purity determination and standard qualification.
Regulatory & Quality: Ensure all synthetic work and documentation align with cGMP expectations and ICH guidelines. Contribute to the preparation of technical reports and regulatory filings.
Mentorship & Safety : Provide technical guidance and mentorship to junior synthetic chemists. Champion a culture of rigorous lab safety, proactive hazard assessment, and immaculate chemical hygiene.
Compliance: Remains compliant with Company, Quality, Environmental Health & Safety, and Drug Enforcement Administration (DEA) policies and procedures.
Inventory: Helps maintain system used to track reference standards inventory.
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