Chemist – Analytical Method Validation
About The Position
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 role works 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. The position is based at Nivagen Pharmaceuticals, 3900 Duckhorn Dr, Sacramento, CA 95834. The successful candidate will perform analytical testing, prepare and review technical documentation and data, support laboratory investigations, and contribute to instrument readiness and validation project execution.
Requirements
- Bachelor’s degree in chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
- 2–5 years of experience in pharmaceutical analytical laboratories.
- 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.
- 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.
Nice To Haves
- Master’s degree.
- Hands-on experience with analytical method validation.
- Experience supporting ANDA, NDA, or commercial pharmaceutical products.
- 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.
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.
Benefits
- Yearly bonus eligibility.
- Medical, dental, and vision coverage.
- Paid time off plan.
- A wide variety of benefits and programs to support health and well-being.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
