Staff Chemist

About This Role

The Staff Synthetic Chemist synthesizes small molecule analytical reference standards for Active Pharmaceutical Ingredient (API) and Drug Product businesses. This critical role involves designing and executing complex, multi-step organic syntheses to generate analytical reference standards, including API impurities, degradants, and metabolites. The chemist will also serve as the technical lead for the Reference Standards Program, collaborating with various teams to ensure compliance with ICH guidelines and cGMP requirements.

Responsibilities

• 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
• Perform advanced isolation and characterization of synthesized compounds using modern analytical techniques (NMR, LC-MS, GC-MS, IR, etc.) to confirm chemical structures
• 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
• Partner with the process chemistry team to identify potential process impurities and with the analytical chemistry team / QC to develop specifications and test methods for purity determination and standard qualification
• Ensure all synthetic work and documentation align with cGMP expectations and ICH guidelines
• Contribute to the preparation of technical reports and regulatory filings
• Provide technical guidance and mentorship to junior synthetic chemists
• Champion a culture of rigorous lab safety, proactive hazard assessment, and immaculate chemical hygiene
• Remain compliant with Company, Quality, Environmental Health & Safety, and Drug Enforcement Administration (DEA) policies and procedures
• Help maintain the system used to track reference standards inventory

Requirements

• Ph.D. in Organic Chemistry with a minimum 3 years of related industrial experience; or MS (thesis preferred) in Organic Chemistry with a minimum 5 years of related industrial experience; or BS in Chemistry with a minimum of 8 years of related industrial experience
• Exceptional track record in organic synthesis

About the Company

At Par Health, we believe great healthcare is built on getting the essentials right. With a global workforce, the company prioritizes quality and safety while fostering a culture of continuous improvement, accountability, and teamwork.