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Sr Research Associate

Location: Fort Collins, Colorado
Job Category:

Independently develops methods of analysis for active ingredients/finished products per established criteria. Performs routine sample analyses, data and document review, and acts as a resource for less experienced analysts.

Essential Duties & Responsibilities
  • Independently develop and validate analytical methods to current ICH and USP guidelines.
  • Accurately analyze formulation, drug, or product samples and assist other departments in analyzing samples as requested.
  • Perform routine sample analyses in support of GLP or R&D stability protocols.
  • Assist the Quality Control laboratory in troubleshooting method issues.
  • Record detailed observations, tabulate, analyze, review, and interpret data from analytical tests.
  • Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies.
  • Write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to governmental agencies.
  • Maintain and review lab notebooks according to cGMPs and GLPs.
  • Perform equipment troubleshooting, maintenance and repairs.
  • May participate in scientific conferences and contribute to scientific journals.
  • Interact closely with project teams across departments, marketing partners, and other outside entities to present technical information.
  • Serve as contact for vendors and contract laboratories.
  • Serve as a resource for a variety of chemical techniques to provide insight for product development issues, clinical and manufacturing problems.
  • Evaluate active pharmaceutical product technical packages for source selection.
  • Provide guidance to less experienced Research Associates.
  • Provide analytical support to Formulation Development and interact with team members in exchanging technical expertise.
  • Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Respond to spills per CP 030-0202 Chemical Spill Response.
  • Perform other related duties as assigned.
Knowledge, Skills & Abilities
  • Experienced with laboratory and wet chemistry techniques (e.g. weighing, volumetric glassware, titrations, etc.).
  • Extensive experience in the operation and maintenance of analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, viscosity.
  • Knowledgeable regarding equipment troubleshooting, maintenance, and repairs.
  • Proficient in sample preparation in a variety of matrices.
  • Proficient in method development and validation.
  • Strong knowledge of government regulations for drugs and medical devices including GMP, GLP and ICH and their application to laboratory processes.
  • Experienced in the use of USP, NF and extraction techniques.
  • Experienced in the effective writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to governmental agencies. Signs for approval of documents for the analytical development department at the discretion of the Director.
  • Effective written and oral communication skills.
  • Extensive experience in the use of word processing, spreadsheet, and database programs.
  • Possesses attention to detail, accurate and precise in data compilation and review.
  • Ability to work well independently, with other analysts, and handle multiple projects and timelines concurrently.
  • Experience with computer systems for sample tracking, laboratory equipment, raw data handling.
Core Values
  • The Senior Research Associate is expected to operate within the framework of Tolmar’s Core Values:
    • Consistently operate with the highest standards of ethics and compliance.
    • Take ownership of your actions, success and setbacks.
    • Respect each other and understand that honest collaboration is at the heart of our company success.
    • Go the extra mile to make things happen.
    • Be committed to all we do and the patients we serve.
    • Embrace change with enthusiasm.
    • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
  • Bachelors’ degree in chemistry or a related discipline.
  • Five or more years of related industry experience or a Masters’ degree combined with 2 or more years of related industry experience.
Working Conditions
  • Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceutical substances.

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