Chemist – Analytical Method Validation

Job Summary:

Nivagen Pharmaceuticals is seeking a highly motivated Chemist – Analytical Method Validation to support analytical method validation, method transfer, troubleshooting, and regulatory compliance activities for pharmaceutical drug substances and drug products. The successful candidate will work closely with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing teams to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.

Nivagen Pharmaceuticals

3900 Duckhorn Dr, Sacramento, CA 95834.

Key Responsibilities:

· Execute analytical method validation and verification studies in accordance with approved protocols and regulatory requirements.

· Perform testing using HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, and other analytical instruments.

· Support method development, optimization, method transfer, and troubleshooting activities.

· Prepare validation protocols, reports, test procedures, and technical documentation.

· Review and analyze analytical data for accuracy, completeness, and compliance.

· Support OOS, OOT, deviation, and laboratory investigation activities as required.

· Maintain laboratory notebooks and electronic records in compliance with GMP and Data Integrity requirements.

· Participate in instrument qualification, calibration, preventive maintenance, and audit readiness activities.

· Collaborate with cross-functional teams to ensure timely completion of validation projects.

Education:

· Bachelor’s degree in chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.

· Master's Degree is a plus.

Experience:

· 2–5 years of experience in pharmaceutical analytical laboratories.

· Hands-on experience with analytical method validation is preferred.

· Experience supporting ANDA, NDA, or commercial pharmaceutical products is desirable.

Technical Skills:

· Strong knowledge of ICH Q2(R2), USP, FDA, and GMP requirements related to analytical method validation.

· Proficiency in HPLC/UPLC operation and data analysis.

· Experience with chromatography data systems such as Empower, Chromeleon, or equivalent software.

· Strong data analysis, troubleshooting, and technical writing skills.

Required Competencies:

· Strong attention to detail and scientific accuracy.

· Excellent organizational and documentation skills.

· Ability to manage multiple projects and meet deadlines.

· Effective verbal and written communication skills.

· Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

· Experience with injectable, sterile, or complex pharmaceutical products.

· Experience with method transfer and QC laboratory support.

· Familiarity with regulatory inspections and compliance requirements.

· Experience preparing validation reports and supporting regulatory submissions.

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.