Summary of the Position: The Analytical Scientist III will be expected to develop, validate, optimize and lead practical analytical methods with no supervision. Responsible to lead peers for timely completion, review of method development / analytical technical reports and weekly updates. Must be able to complete assigned tasks and major projects consistently with urgency and initiative.

EDUCATION AND EXPERIENCE

• A bachelor’s degree in Chemistry with 7 years of experience in method development and validation of analytical methods for nutraceuticals and/or pharmaceutical samples in a GMP environment. If degree has concentration; Biochemistry, Inorganic, Physical or Polymer Chemistry preferred; or, a Master’s/Ph.D. degree in Chemistry with a minimum of 5 years of technical experience in a GMP environment.
• Must have prior experience of working on the bench as this position is primarily on the bench working in the laboratory.

Safety Requirements:

• Participates without hesitation in all safety initiatives, consistently exhibits an excellent safety record and ensures proper safety practices are followed in the laboratory.
• Responsible for producing and handling hazardous waste from point of generation to satellite storage. Hazardous waste produced is managed in accordance with RCRA and SCDHEC regulations and includes: proper containers, accumulation, labeling, marking and storage.
• Must have a Safety-First mindset and be aware of surroundings while working in the laboratory.
• Maintains a safe work environment and ensures all instruments used in testing procedures are calibrated and properly maintained

Minimum Requirements:

• Understands urgency and initiative to drive projects/assignments to completion.
• Capable of developing analytical methods for chromatographic, spectroscopic, titrimetric and wet chemistry analyses.
• Is proficient with laboratory instrument troubleshooting.
• Intermediate to advanced understanding in most laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS/MS, GC-MS, ICP-MS/OES and HPTLC.
• Has knowledge in the characterization and elucidation of botanical compound structures by study of the compound structure, spectroscopic methods and mass spectrometry.
• Knowledge required in the selection of analytical columns for chromatographic analyses, proper techniques or technologies and the selection for proper reagents to design effective analytical methods in timely manner.
• Knowledge in effective sample preparation techniques to support high number of samples for testing such as liquid-liquid extraction, derivatization, chemical manipulation and mechanical manipulation.
• Knowledge of statistical techniques, such as data trend analysis and design of experiments is highly desirable. Proficient in reviewing and interpretation of laboratory data.
• Detailed knowledge in principles of routine laboratory operations.
• Thorough working knowledge of industry regulations, FDA and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
• Proven ability to communicate effectively and cooperatively within all levels of an organization.
• Strong communicator both verbal and written.
• Demonstrated aptitude to function in a dynamic fast-paced environment

Testing:

• Willingness to assists with Quality Release testing as needed, Special Request testing of finished products and raw materials and Stability samples either following Standard Operating Procedures (SOPs) and in-house test methods, compendial methods or methods still in the development phase.
• Capable of assessing testing methodologies and their application to different sample matrix including evaluation of testing results from contract laboratories to ensure agreed upon methods and testing parameters were properly followed.

Laboratory Instrumentation/Software:

• Ability to troubleshoot all Analytical instruments such as HPLC, GC, ICP-MS/OES and LC-MS/MS.
• Good knowledge of experimental design, chemical theory and analytical instrumentation theory for HPLC, GC, ICP-MS/OES and LC-MS/MS.
• Proficient in Empower, Tiamo, MassHunter and MassLynx software and other laboratory software used in the Quality Laboratory environment for chromatographic and spectroscopic methods.

Mentoring and Teamwork:

• Takes initiative to consistently act as a mentor to others and helps others without having to be asked.
• Is flexible to changes in priorities with projects and assignments and can adapt to laboratory improvements implemented from management and/or peers.
• Has the aptitude to take the lead and provide technical support with the optimization of analytical methods used for marketed products and products in the development phase.
• Can mentor and train junior chemists in the proper execution of laboratory techniques including interpretation of development and validation studies.
• Assists with training of new laboratory personnel in accordance with established laboratory SOPs and the Nutramax training program. Possesses techniques and tools to successfully train others with empirical data to support training.

Safety Requirements:

• Participates without hesitation in all safety initiatives, consistently exhibits an excellent safety record and ensures proper safety practices are followed in the laboratory.
• Responsible for producing and handling hazardous waste from point of generation to satellite storage. Hazardous waste produced is managed in accordance with RCRA and SCDHEC regulations and includes: proper containers, accumulation, labeling, marking and storage.
• Must have a Safety-First mindset and be aware of surroundings while working in the laboratory.
• Maintains a safe work environment and ensures all instruments used in testing procedures are calibrated and properly maintained.

General Responsibilities:

• The Analytical Scientist III is capable of planning, directing, layout design and coordination of analytical activities in order to ensure the success of projects from initiation through completion and full implementation.
• Acts as a liaison to resolve product quality, technical or operational issues and support of commercial products.
• Capable of working with outside departments such as Operations, Innovations, Marketing, Purchasing and Engineering to investigate external and internal quality and compliance related issues.
• Familiarity and supportive of all Analytical projects and Special Request testing.
• Works closely with the Innovations team to be aware of timely testing of samples to facilitate decision making.
• Effective and practical development and validation of scientifically sound analytical methods to ensure analysis and prompt release of raw materials, finished products and stability studies.
• Design and execute method transfer protocols of analytical methods oriented to the timely manner release of Quality Laboratory samples.
• Ensure competency of ISO 17025 test methods are current as needed.
• Maintain current knowledge of latest technological and scientific trends and serves as an expert resource for the Quality department.
• Perform other assigned duties as may be required in meeting company objectives.
• Communicate effectively with other departments within the organization and function within a team environment.
• Regular attendance is required.

Minimum Requirements:

• Understands urgency and initiative to drive projects/assignments to completion.
• Capable of developing analytical methods for chromatographic, spectroscopic, titrimetric and wet chemistry analyses.
• Is proficient with laboratory instrument troubleshooting.
• Intermediate to advanced understanding in most laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS/MS, GC-MS, ICP-MS/OES and HPTLC.
• Has knowledge in the characterization and elucidation of botanical compound structures by study of the compound structure, spectroscopic methods and mass spectrometry.
• Knowledge required in the selection of analytical columns for chromatographic analyses, proper techniques or technologies and the selection for proper reagents to design effective analytical methods in timely manner.
• Knowledge in effective sample preparation techniques to support high number of samples for testing such as liquid-liquid extraction, derivatization, chemical manipulation and mechanical manipulation.
• Knowledge of statistical techniques, such as data trend analysis and design of experiments is highly desirable. Proficient in reviewing and interpretation of laboratory data.
• Detailed knowledge in principles of routine laboratory operations.
• Thorough working knowledge of industry regulations, FDA and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
• Proven ability to communicate effectively and cooperatively within all levels of an organization.
• Strong communicator both verbal and written.
• Demonstrated aptitude to function in a dynamic fast-paced environment.