Sr. Scientist, Analytical Method Validation – Sacramento

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision

Paid time off

Annual bonus eligibility

Job summary

Nivagen Pharmaceuticals Inc. is seeking a Sr. Scientist for Analytical Method Validation in Sacramento, CA. You will develop, validate, transfer, and troubleshoot analytical methods across drug substances and products, ensuring compliance with cGMP and regulatory standards.

You will lead method transfer activities, oversee data integrity, and support regulatory submissions while mentoring junior scientists in a fast-paced team environment driven by quality and efficiency.

Qualifications

• Ph.D. with 2+ years pharmaceutical analytical experience or MS with 5+ years; BS with 8+ years.
• Experience in method development, validation, transfer, troubleshooting in pharma.
• Familiarity with regulatory submissions and cGMP environments.

Responsibilities

• Develop, validate, transfer, troubleshoot, and maintain analytical methods for drugs and materials.
• Ensure adherence to cGMP, GLP, data integrity and regulatory requirements.
• Coordinate method transfers between R&D, QC, manufacturing, and CMOs.
• Review data for accuracy, completeness, and compliance with data integrity.
• Lead investigations and CAPAs for OOT results or deviations.

Skills

HPLC/UPLC

GC Headspace

ICP-MS

FTIR

Dissolution Testing

Data Integrity Compliance

Stability Study Support

Root Cause Analysis

LIMS

Regulatory Submissions

Education

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline

M.S. in Chemistry, Pharmaceutical Sciences, or related field

B.S. in Chemistry or related field

Tools

Waters Empower

Job description

Nivagen Pharmaceuticals Inc. is seeking a Sr. Scientist for Analytical Method Validation in Sacramento, CA. You will develop, validate, transfer, and troubleshoot analytical methods across drug substances and products, ensuring compliance with cGMP and regulatory standards.

You will lead method transfer activities, oversee data integrity, and support regulatory submissions while mentoring junior scientists in a fast-paced team environment driven by quality and efficiency.