Associate Scientist III - Onsite

Purpose and Scope

With 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.

• 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.

• 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.

This 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…