Senior Analytical Scientist - Method Development & Validation

Tolmar; Fort Collins (CO); On-site; USD 92,000 - 105,000; Full time

Job summary

Tolmar in Fort Collins, CO, seeks an analytical development scientist to independently develop, test, and validate methods for active ingredients, raw materials, and finished products.

Under senior guidance, you'll contribute to method development, change controls, investigations, and support QA teams, while training others and ensuring cGMP compliance. You will apply regulatory guidelines and employ instrumentation to solve problems and improve product quality.

Qualifications

• BS or MS in Chemistry or related field; PhD acceptable.
• Minimum experience: 6+ years with BS; 4+ years with MS; 2+ years with PhD in industry.
• Experience with regulatory requirements (FDA, DEA, cGMP) and quality systems.

Responsibilities

• Develop and validate analytical methods for APIs, raw materials, and finished products.
• Review data and documents; provide SME-level guidance.
• Assist other departments with sample analyses as requested.
• Troubleshoot analytical method issues; propose improvements for QC lab.
• Train and coach others; lead small projects.

Skills

Analytical development

Method validation

cGMP & FDA

Data analysis

SOP writing

Training others

Instrumentation SME

Regulatory compliance

Education

BS in Chemistry or related field

MS in Chemistry or related field

PhD in Chemistry or related field

Tools

HPLC

Chromatography

IQ/OQ processes

Job description

Tolmar in Fort Collins, CO, seeks an analytical development scientist to independently develop, test, and validate methods for active ingredients, raw materials, and finished products.

Under senior guidance, you'll contribute to method development, change controls, investigations, and support QA teams, while training others and ensuring cGMP compliance. You will apply regulatory guidelines and employ instrumentation to solve problems and improve product quality.