QC chemist

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: QC Chemist

As a QC 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.

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).

Qualifications:

Education/Experience:

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
• 1-5 years of experience in a pharmaceutical quality control laboratory.

Knowledge, Skills, and Abilities:

• Proficiency in analytical techniques (HPLC, GC, FTIR, UV-Vis, Dissolution Testing, etc.).
• Strong understanding of pharmaceutical regulations (FDA and ICH).
• Experience with GMP, GLP, and GDP requirements.
• 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.

Requirements:

• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Pay range $75,000-$85,000 per Year
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.