Research Chemist

Nivagen Pharmaceuticals•Sacramento, CA

2d•Onsite

About The Position

As a chemist at Nivagen you will be responsible for conducting analytical tests on pharmaceutical products, ensuring that they meet regulatory standards such as those set by the FDA and ICH. This role involves performing tests on raw materials, intermediates, and finished dosage forms to guarantee product safety, efficacy, and quality in compliance with Good Manufacturing Practices (GMP) and other regulatory standards.

Requirements

Proficiency in analytical techniques (HPLC, GC, FTIR, UV-Vis, Dissolution Testing, etc.).
Strong understanding of pharmaceutical regulations (FDA and ICH).
Ability to troubleshoot analytical issues and conduct root cause analysis.
Strong communication and documentation skills.
Excellent attention to detail and organizational skills.
Familiarity with FDA, ICH guidelines, including ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System).
Knowledge of stability testing guidelines, including ICH Q1A.
Ability to stand and work for extended periods in a laboratory environment.
Comfortable handling chemicals and pharmaceutical substances.
Experience with GMP, GLP, and GDP requirements.

Responsibilities

Operate and maintain analytical instruments such as GC, GC-MS, LC-MS, UPLC, and HPLC, which are equipped with UV-Vis, PDA, and CAD detectors.
Ensure proper calibration and regular maintenance of laboratory equipment to guarantee accuracy and precision in results.
Assist in developing and validating analytical methods for new products, ensuring compliance with regulatory guidelines, including those from ICH and FDA.
Perform qualitative and quantitative analyses on raw materials, in-process materials, and finished products using validated methods to ensure compliance with required specifications.
Conduct stability studies on products following ICH guidelines, adhering to stability protocols, and documenting results for regulatory submissions.
Investigate deviations and out-of-specification (OOS) results, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
Ensure all testing adheres strictly to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory standards.
Implement ICH Q2 (R1) guidelines for method validation and participate in internal and external audits to maintain laboratory compliance.
Collaborate with R&D, production, and quality assurance teams to support product development and commercialization efforts, and provide assistance during regulatory inspections.
Perform any additional tasks as assigned by the Chief Scientific Officer (CSO).