Analytical Method Validation Chemist — Growth & Impact

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

Benefits offered by this job

Yearly bonus

Medical, dental, and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a Chemist – Analytical Method Validation to support method validation, transfer, troubleshooting, and regulatory activities for drug substances and products at our Sacramento site.

The role collaborates with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.

Qualifications

• Bachelor’s degree in chemistry or related field.
• 2–5 years in pharmaceutical analytical laboratories.
• Hands-on experience with analytical method validation.
• Experience supporting ANDA/NDA or commercial products desirable.
• Strong knowledge of ICH Q2(R2), USP, FDA and GMP.

Responsibilities

• Execute analytical method validation and verification studies per protocols and regulatory requirements.
• Perform testing using HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR and other instruments.
• Support method development, optimization, transfer and troubleshooting activities.
• Prepare validation protocols, reports, test procedures and documentation.
• Review and analyze analytical data for accuracy and compliance.
• Support OOS, OOT, deviation and laboratory investigations as required.
• Maintain notebooks and electronic records in GMP/data integrity compliance.
• Participate in instrument qualification, calibration and maintenance.
• Collaborate with cross-functional teams to meet project timelines.

Skills

HPLC/UPLC operation

Data analysis

Technical writing

Regulatory compliance

GMP knowledge

Education

Bachelor's degree in chemistry

Master's degree (preferred)

Tools

Empower

Chromeleon

Job description

Nivagen Pharmaceuticals is seeking a Chemist – Analytical Method Validation to support method validation, transfer, troubleshooting, and regulatory activities for drug substances and products at our Sacramento site.

The role collaborates with Analytical R&D, Quality Control, Quality Assurance, and Manufacturing to ensure analytical methods are validated in accordance with ICH, USP, FDA, and internal requirements.