Analytical Method Validation Chemist – Pharma, HPLC

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a Chemist – Analytical Method Validation to support validation, transfer, troubleshooting, and regulatory compliance for drug substances and products.

The role collaborates with Analytical R&D, Quality Control, QA, and Manufacturing to ensure methods meet ICH, USP, FDA, and internal requirements. The position emphasizes hands-on validation work, data analysis, and documentation, with a focus on accuracy, audit readiness, and timely project delivery in a

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, biochemistry, or related field.
• Master's degree is a plus.
• 2–5 years of pharmaceutical analytical lab experience.
• Hands-on method validation experience preferred.
• Experience supporting ANDA, NDA, or commercial products desirable.

Responsibilities

• Execute analytical method validation and verification per protocols and regulatory requirements.
• Perform testing using HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, and other analytical instruments.
• Support method development, transfer, and troubleshooting activities.
• Prepare validation protocols, reports, test procedures, and technical documentation.
• Review analytical data for accuracy, completeness, and compliance.
• Support OOS, OOT, deviation, and laboratory investigation activities as required.
• Maintain laboratory notebooks and electronic records in GMP and Data Integrity compliance.
• Participate in instrument qualification, calibration, preventive maintenance, and audit readiness.
• Collaborate with cross-functional teams to ensure timely completion of validation projects.

Skills

HPLC/UPLC

Data analysis

Troubleshooting

Method validation

Education

Bachelor's degree in chemistry

Master's degree (plus)

Tools

Empower

Chromeleon

Job description

Nivagen Pharmaceuticals, Inc. is seeking a Chemist – Analytical Method Validation to support validation, transfer, troubleshooting, and regulatory compliance for drug substances and products.

The role collaborates with Analytical R&D, Quality Control, QA, and Manufacturing to ensure methods meet ICH, USP, FDA, and internal requirements. The position emphasizes hands-on validation work, data analysis, and documentation, with a focus on accuracy, audit readiness, and timely project delivery in a