Research Chemist

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a chemist to perform analytical testing on raw materials, intermediates, and finished dosage forms in a GMP-regulated lab in California. You will ensure product safety, efficacy, and quality in line with FDA/ICH standards.

Responsibilities include operating GC/LC-MS/UHPLC systems, validating methods, and supporting regulatory submissions. The role requires strong problem-solving, documentation, and cross-functional collaboration with QA, R&D, and

Qualifications

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
• 1-5 years of experience in a pharmaceutical quality control laboratory.
• Experience with GMP, GLP, and GDP requirements.
• Proficiency with analytical techniques (HPLC, GC, UV-Vis, FTIR) and method validation.

Responsibilities

• Operate and maintain analytical instruments (GC, GC-MS, LC-MS, UPLC, HPLC) with detectors (UV-Vis, PDA, CAD).
• Calibrate and maintain laboratory equipment to ensure accuracy and precision.
• Develop and validate analytical methods compliant with ICH and FDA guidelines.
• Perform qualitative and quantitative analyses on materials and finished products.
• Conduct stability studies per ICH guidelines and document results for regulatory submissions.
• Investigate deviations and conduct CAPA to address root causes.
• Ensure testing adheres to GLP, GMP, GDP, and other regulatory standards.
• Assist in audits and collaborations with R&D, production, and QA teams.

Skills

HPLC

GC

LC-MS

UPLC

UV-Vis

Dissolution Testing

FDA & ICH regulations

Root cause analysis

Troubleshooting

Documentation

Communication

GMP/GLP/GDP

ICH Q2(R1) and Q1A

Education

Bachelor's or Master's in Chemistry/Pharmaceutical Sciences/Biochemistry

1-5 years in pharmaceutical QC lab

Experience with GMP/GLP/GDP requirements

Tools

GC-MS

HPLC systems

LC-MS

UPLC/UV detectors

Analytical method validation

Job description

Job Summary: 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.

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)

Required Skills/Abilities

• 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.

Education and 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.
• Experience with GMP, GLP, and GDP requirements.

Physical Requirements/ Working Conditions

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. Nivagen is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Nivagen will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Nivagen uses E-Verify.

Nivagen is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine‑containing substances is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining Nivagen, you agree to adhere to our nicotine‑free workplace policy, which supports a healthier environment for all employees.