Research Chemist

nivagenpharmaceuticals; Sacramento (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

Nivagen is seeking a chemist to perform analytical testing on raw materials, in-process materials, and finished dosage forms. You will ensure data quality and regulatory compliance under GMP, GLP, GDP, and ICH/FDA guidelines.

The role involves method development and stability studies, supporting product development and regulatory submissions, with emphasis on accurate data generation and collaboration with QA and R&D teams.

Qualifications

• Bachelor's or Master's in Chemistry/Pharma or related field.
• 1–5 years of experience in a pharmaceutical quality control lab.
• Experience with GMP, GLP, and GDP requirements.
• Familiarity with regulatory guidelines (ICH/FDA) is preferred.

Responsibilities

• Operate and maintain analytical instruments (GC, GC-MS, LC-MS, HPLC) with UV-Vis, PDA, and CAD detectors.
• Ensure calibration and routine maintenance of lab equipment for accuracy and precision.
• Develop and validate analytical methods per ICH and FDA guidelines.
• Perform quantitative/qualitative analyses on materials using validated methods.
• Conduct stability studies following ICH guidelines and document results for submissions.

Skills

HPLC

GC/GC-MS

ICH/FDA guidelines

GLP/GMP/GDP compliance

Analytical method development

Education

Bachelor's or Master's in Chemistry/Pharma

Tools

GC/LC-MS instruments

FTIR/UV-Vis equipment

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…
• 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.