Senior Scientist, Analytical Method Validation & Transfer

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

Benefits offered by this job

Competitive Salary

Annual bonus

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a Sr. Scientist – Analytical Method Validation in the Sacramento area.

This role leads development, validation, transfer, troubleshooting, and maintenance of analytical methods for drug substances and products, ensuring cGMP/GLP compliance and regulatory readiness. The Senior Scientist will support regulatory submissions, technology transfer, and commercial manufacturing, while upholding data integrity and laboratory discipline across QA, QC, and

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related field with 2+ years of experience; OR
• M.S. with 5+ years of analytical pharmaceutical industry experience; OR
• B.S. with 8+ years of relevant experience.

Responsibilities

• Develop, validate, transfer, troubleshoot analytical methods for drug substances/products and related materials.
• Ensure compliance with cGMP, GLP, ICH, USP, and regulatory requirements.
• Coordinate method transfer between R&D, QC, manufacturing, and CMOs.

Skills

Analytical thinking

Regulatory knowledge

Project management

Leadership & mentoring

Attention to detail

Time management

Education

Ph.D. in Analytical Chemistry or related

M.S. in Chemistry/Pharmaceuticals

B.S. in Chemistry or related

Tools

LIMS

Microsoft Office

Job description

Nivagen Pharmaceuticals, Inc. is seeking a Sr. Scientist – Analytical Method Validation in the Sacramento area.

This role leads development, validation, transfer, troubleshooting, and maintenance of analytical methods for drug substances and products, ensuring cGMP/GLP compliance and regulatory readiness. The Senior Scientist will support regulatory submissions, technology transfer, and commercial manufacturing, while upholding data integrity and laboratory discipline across QA, QC, and