Purpose and ScopeWith minimal supervision, independently develops, tests, and validates methods of analysis for active ingredients/finished products per established criteria. Performs routine and some non-routine sample analyses, data and document review, and acts as a resource for less experienced analysts. Uses in-house standard operating procedures and pharmaceutical industry knowledge.
Essential Duties & Responsibilities- Independently develops and validates methods for the analysis of active pharmaceutical ingredients, raw materials, and finished products.
- Under the guidance of senior scientists, participate in Analytical Development process review and development, including change controls, investigations, and department support initiatives.
- Assist other departments in analyzing samples, as requested and appropriately trained.
- Participates in scientific discussions and brainstorming activities during the product development process.
- Provide troubleshooting, solutions and strategies for method issues and improvements for the QC lab.
- Use technical discretion and critical thinking in designing, executing, and interpreting experiments, drawing conclusions, and proposing future studies.
- Participate in scientific conferences as appropriate.
- Perform equipment troubleshooting. Established as SME for an instrument. Propose new instrumentation and participate in URS, acquisition, and IQ/OQ process.
- Serve as a subject matter expert (SME) and train others in areas of expertise. Maintains current technology and practices within the SME area.
- Independently apply regulations for drugs and medical devices, including USP, ICH and FDA regulations for cGMP and GLP. Interpret regulatory guidance and provide suggestions for internal practice.
- Learn to train and coach others on specific tasks with appropriate management support.
- Learn to serve as a project lead with appropriate management support.
- Serve as contact for vendors and contract laboratories. Responsible for the scientific merit, interpretation, review, and output of data from external partners.
- Participate in Core Team/Technical Team meetings, provide analytical updates and technical issues, facilitate problem-solving technical discussions, and provide FMEA to TPRC/IPRC.
- Perform other related duties as assigned.
Knowledge, Skills & Abilities- 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.
Core ValuesThis 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 and treat 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 with an enterprise-wide mindset that lifts the whole organization.
- 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk-taking that drives better ways of working.
- 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- 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
Working Conditions- Office, laboratory, and pharmaceutical manufacturing setting. Will be exposed to solvents, biohazardous materials, hazardous waste, and pharmaceuticals.
- Work may require lifting objects up to 25 lbs. and the use of a respirator.
- Some travel may be required.
Compensation and Benefits- Annual pay range $92,000 - $105,000
- Benefits information: 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.
