Lead Analytical Scientist – Method Development & Validation

Tolmar Inc.; Fort Collins, Northern (CO, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Tolmar Inc. in Fort Collins seeks an analytical development scientist who independently develops, tests, and validates methods for APIs, raw materials, and finished products with minimal supervision.

You will interpret data, ensure compliance with FDA/cGMP, train others as SME, and collaborate across departments to advance product development and quality. Strong troubleshooting, robust documentation, and ongoing engagement in technical teams and conferences are expected to drive improvements and

Qualifications

• BS or MS in Chemistry or related field; PhD acceptable.
• 6+ years with BS; 4+ years with MS; 2+ years with PhD with 2+ years of relevant industry experience.

Responsibilities

• Independently develops and validates analytical methods for APIs, raw materials, and finished products.
• Under guidance of senior scientists, participate in method development, change controls, investigations.
• Assist other departments in analyzing samples.
• Participate in scientific discussions during product development.
• Provide troubleshooting and strategies for method issues in QC lab.
• Design, execute, and interpret experiments with scientific rigor.
• Present at scientific conferences as appropriate.
• Perform equipment troubleshooting; act as SME for an instrument; propose new instrumentation.
• Train others as SME; stay current in area of expertise.
• Apply FDA, ICH, cGMP regulations in development.
• Lead training/development, and potentially project lead responsibilities.
• Coordinate with vendors/contract labs; review external data.
• Participate in Core/Technical Team meetings and perform FMEA.

Skills

Wet chemistry

Chromatography

Data analysis

Regulatory knowledge

SOP writing

Analytical method development

Education

BS in Chemistry or related field

MS in Chemistry or related field

PhD in Chemistry or related field

Job description

Tolmar Inc. in Fort Collins seeks an analytical development scientist who independently develops, tests, and validates methods for APIs, raw materials, and finished products with minimal supervision.

You will interpret data, ensure compliance with FDA/cGMP, train others as SME, and collaborate across departments to advance product development and quality. Strong troubleshooting, robust documentation, and ongoing engagement in technical teams and conferences are expected to drive improvements and