Description

Purpose and Scope Independently develops, tests, validates and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency. Mentors less experienced analysts. The Scientist uses in-house standard operating procedures, compendial documents, industry guidances and pharmaceutical industry knowledge to perform tasks. The Scientist fosters an environment of safety and company culture. Essential Duties & Responsibilities Apply and stay current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently. Advise on project decisions with potential regulatory consequences. Adhere to validated test methods, standard operating procedures, and applicable industry guidance. Knowledgeable in the execution of compendial methods, specifically USP and EP. Independently perform sample analyses. Efficiently analyze samples of drug product, drug substance, and/or excipient(s). Assist other departments in analyzing samples, as requested. 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 submission to government agencies. Use technical discretion in designing, executing, and interpreting 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 to Formulation Development and interact with team members in exchanging technical expertise. Serve as a subject matter expert (SME) (instrumentation, methodology, guidance, etc.) and train others in several areas of expertise Apply statistics for analytical chemistry, data trending, out of specification data, and method development and validation. Perform risk assessments for supplier and compendial changes. Serve as a project lead with little to no supervision. Allocate lab resources effectively (staff, budget, materials, etc.). Introduce new concepts, practices, instrumentation, techniques, and methodology that can be leveraged to solve current research questions. Advise senior management on project technical details Express scientific creativity in solving current R&D challenges. Participate 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 report, protocol, test method, and specification approvals. Perform other related duties as assigned. Knowledge, Skills & Abilities Knowledge Demonstrated proficiency in operating 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. Experience with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory. Advanced writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies. Demonstrated understanding of drug product formulation development. Demonstrated understanding of critical quality attributes (CQAs) of drug products based on formulation and stability. Extensive experience with laboratory and wet chemistry techniques (e.g., weighing, volumetric glassware, titrations, etc.). Experience in equipment troubleshooting, maintenance, and repairs. Experience with the use of electronic document management system(s). Extensive experience using 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 Scientist II is expected to operate within the framework of Tolmar's