Research Associate II - AS (Onsite)

Purpose and Scope

Under limited supervision the analyst develops, tests, and validates test methods of analysis for excipients, active ingredients, and finished products per established criteria. Perform routine sample analyses, data review, document review, test method development, and acts as a resource for less experienced analysts. This analyst may also perform laboratory investigations. The analyst uses in-house standard operating procedures and pharmaceutical industry knowledge. The analyst fosters an environment of safety and company culture.

Essential Duties & Responsibilities

• Apply regulations for drugs and medical devices, including USP, ICH and FDA regulations for cGMP and GLP independently.
• Adhere to validated test methods, standard operating procedures, and applicable industry guidance.
• Independently perform sample analyses in support of GLP and/or GMP protocols.
• Efficiently analyze samples of drug product, drug substance, and/or excipient(s).
• Assist other departments in analyzing samples, as requested.
• Perform laboratory investigations.
• Maintain and review laboratory notebooks according to cGMP standards and in-house standard operating procedures (SOPs).
• Record detailed observations, tabulate, analyze, review, and interpret data from analytical tests.
• Lead analytical test method design, development, qualification, and validation.
• Perform equipment troubleshooting, maintenance, and minor repairs.
• Assist the Quality Control (QC) laboratory in troubleshooting test method issues.
• Efficiently write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or for submission to government agencies.
• Use technical discretion in the design, execution, and interpretation of experiments that contribute to project strategies.
• Participate in required trainings.
• Serve as contact for vendors and contract laboratories.
• Interact closely with project teams across departments and outside testing laboratories.
• Interpret, review, and discuss data from outside testing laboratories.
• Mentor, train, and coach others.
• Participate in scientific conferences if requested.
• Provide analytical support and interact other department with team members in exchanging technical expertise.
• Learn to become a subject matter expert (SME) (instrumentation, methodology, guidance, etc.).
• Learn basic statistics for analytical chemistry, data trending, out of specification data, and method development and validation.
• 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. Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers. Respond to spills according to the Chemical Spill Response procedure.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

Knowledge

• Proficient in the operation of analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, rheometry.
• Proficient with sample preparation from a variety of matrices.
• Proficient with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.
• Proficient 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 government agencies.
• Demonstrated understanding of drug product formulation development.
• Basic understanding of common critical quality attributes (CQAs) of drug products based on formulation and stability.
• Experience in equipment troubleshooting, maintenance, and repairs.
• Experience with the use of electronic document management system(s).
• Extensive experience with the use of word processing, spreadsheet, and database programs. Experienced with MS Office.
• Experience with computer systems for sample tracking, laboratory equipment, and raw data handling.

Skills

• Demonstrated proficiency with test method development and validation.
• Effective written and oral communication skills.

Abilities

• Learn and apply new techniques
• Ability to present in team meetings.
• Attention to detail. Efficient, accurate, and consistent in data compilation and review.
• Work independently and with other analysts, handle multiple projects and timelines concurrently.
• Demonstrate problem-solving in a timely manner.

Core Values

• The position is expected to operate within the framework of Tolmar's Core Values:




• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's or graduate degree in chemistry or related field.
• Three or more years of related analytical laboratory experience, a minimum of one year in a pharmaceutical environment is preferred, with an emphasis on methods development and validation.

Working Conditions

• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceutical substances.
• May need to travel between sites in Colorado.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines.

Compensation and Benefits

• Salary $70,000 to $73,000 depending on experience.
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.