Senior Analytical Method Developer

Tolmar-7; Fort Collins (CO); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Equal opportunity employer

Job summary

Tolmar is seeking an experienced analytical chemist to independently develop, validate, and apply methods for analysis of active ingredients, raw materials, and finished products in a GMP environment. You will interpret results, write technical reports, and lead procedural improvements while ensuring regulatory compliance in cGMP and GLP settings.

You will collaborate with cross‑functional teams, train staff, and participate in change controls and investigations to advance product development

Qualifications

• Mastered all key routine lab analysis techniques, including wet chemistry and chromatography methods.
• Independently studies and analyzes results to draw scientific conclusions.
• Maintain and review laboratory notebooks according to applicable cGMP or R&D standards and in-house SOPs.
• Record detailed observations. Tabulate, analyze, and interpret data from analytical tests with appropriate supervision.
• Compliance with FDA, DEA, cGMP regulations, in-house SOPs, and EH&S policies.
• Consider company and project budgets when requesting reagents and consumables.
• Proficient in error-free writing and reviewing of technical reports, summaries, protocols, test methods, and SOPs.
• Excellent verbal communication and interpersonal skills.
• Serve as SME (instrumentation, methodology, guidance) and train others in area of expertise.
• Knowledge of regulations for drugs and medical devices. Can independently apply regulations during development.
• Independently apply statistics for analytical chemistry, data trending, OOS data, and method development/validation.
• Understand and select appropriate analytical instrumentation to solve technical problems.
• Fosters an environment of safety and company core values.

Responsibilities

• Independently develops, tests, and validates methods for analysis of APIs, raw materials, and finished products.
• Under supervision, participate in Analytical Development process review and development, including change controls and investigations.
• Assist other departments in analyzing samples as trained.
• Participate in scientific discussions during product development.
• Provide troubleshooting, solutions for method issues and improvements for the QC lab.
• Apply regulations for drugs and medical devices during development.
• Train and coach others on tasks and potentially lead projects.
• Serve as contact for vendors and external labs; ensure scientific merit of data.

Skills

Analytical chemistry

Wet chemistry

Chromatography

Data analysis

Regulatory compliance

Technical writing

Training others

Problem solving

Education

BS in Chemistry or related field

MS in Chemistry or related field

PhD in Chemistry or related field

Tools

Analytical instrumentation

IQ/OQ documentation

Job description

Tolmar is seeking an experienced analytical chemist to independently develop, validate, and apply methods for analysis of active ingredients, raw materials, and finished products in a GMP environment. You will interpret results, write technical reports, and lead procedural improvements while ensuring regulatory compliance in cGMP and GLP settings.

You will collaborate with cross‑functional teams, train staff, and participate in change controls and investigations to advance product development