Job Description SummaryThe 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 DescriptionEssential 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.
Qualifications- Education/Experience: Ph.D. in Organic Chemistry with a minimum 3 years of related industrial experience; MS (thesis preferred) in Organic Chemistry with a minimum 5 years of related industrial experience; BS in Chemistry with a minimum of 8 years of related industrial experience.
- Technical Expertise: Exceptional track record in organic synthesis, reaction mechanisms, and route scouting. Demonstrated proficiency in advanced purification techniques (normal/reverse-phase flash chromatography, prep-HPLC, crystallization).
- Analytical Acumen: Able to interpret complex NMR spectra and mass spectrometry data for structural elucidation of unknown or complex organic molecules.
- Industry Knowledge: Strong understanding of pharmaceutical development, API manufacturing, and the role of reference standards in analytical method development and validation. Familiarity with cGMP, FDA, and ICH regulatory guidelines.
- Communication Skills: Excellent technical writing skills for maintaining laboratory notebooks, drafting CoAs, and authoring comprehensive technical reports.
- Problem-Solving: Proven ability to work independently in a fast-paced environment, adapt to shifting priorities, and creatively overcome difficult synthetic roadblocks.
Working ConditionsStandard laboratory conditions within a DEA-regulated environment. Employees must wear eye protection, lab coat, and safety shoes while in the lab area. Occasional handling of potent compounds or hazardous chemicals may require the use of additional PPE. May occasionally be required to lift and/or move up to 25 lbs. Must be able to pass background check and drug test for handling of controlled substances.
