NATURE & SCOPE
The technical manager’s primary functions are to oversee, develop and validate new methods for routine use,
maintain instrumentation, provide technical guidance to staff and customers. Training staff on advanced instrumentation operation for the accurate method transfer to the quality control operations for a 3rd party testing lab. Duties will also include working with management in the evaluation of method development costs and on-going operational costs of running methods for routine testing where cost/benefit can be considered as methods are added to the lab.
The responsibilities of the Associate Chemist include; but are not limited to, the following: The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
• Provide technical advice regarding the following to include, but not be limited to: audits, methodologies, method development, instrumentation, and associated capabilities related to these areas.
• Develop, validate, and implement advanced testing methodologies for instrumentation including HPLC, LC MS/MS, GC/MS, GC/FID, ICP, etc. and continuously improve methods as technology advances.
• Develop, implement, and train staff with advanced laboratory instrumentation methods, operation, maintenance and calibration for equipment including HPLC, LC MS/MS, GC/MS, GC/FID, ICP or other chemistry instumentation.
• Advise on capabilities and assist on quoting projects using advanced equipment methods as needed for customers to submit samples for 3rd party contract chemistry testing.
• Direct work, conduct performance appraisals, reward and/or discipline employees, address complaints and resolve problems.
• Offer thorough equipment, reagent, supply lists, etc. to include what is needed for each method development project so accurate costs can be determined for return on investment decisions.
• Review and release test results to customers to include a detailed technical explanation when applicable.
• Respond to customer requests, inquiries, and complaints and perform investigations when required.
• Design and perform special projects for internal and external customers.
• Advise on and review sample submissions for business team to verify in house method capabilities or recommend outsource testing if testing specifications are below our internal equipment limit of quantitation.
• Research compendia and be able to perform method transfers and /or method development activities following internal SOPs and comply with ISO, FDA, and TGA and other regulatory requirements.
• Author and/or revise general methods needed for the implementation and transfer of the method to the QC department of our 3rd party testing lab following the proper documentation practices required.
• Coordinate the proper maintenance, repair, calibration and operation of instrumentation following all ISO, FDA or other regulatory guidelines.
• Develop, implement and continuously improve the systems, procedures and record-keeping necessary for the organized and efficient receipt of samples for in-house chemistry testing.
• Develop, implement, and control the systems, procedures and record-keeping necessary for the organized and efficient reporting, peer-review, and archiving of laboratory testing & calibration data.
• Oversee the accuracy of test records and per-review analytical and calibration work performed as required for regulatory and ISO compliance.
• Troubleshoot anomalous results generated by the laboratory. Perform testing in support of OOS investigations.
• Maintain the safe and correct use and disposal of laboratory chemicals, solvents, etc., following all federal, state and local guidelines using GMP, GLP and other safe laboratory practices.
• Perform other roles and responsibilities per the Quality Manual.
• Bachelor of Science in Chemistry, Biochemistry or related field and at least five years of laboratory experience or equivalent combination of education and experience. Previous pharmaceutical, supplement or food testing experience preferred. Experience
• Previous laboratory experience
• Basic laboratory skills (e.g. pipetting, weighing, dilutions, etc.)
• Proficient mathematical skills
• Demonstrate expertise and proficiency with advanced analytical techniques and state-of-the-art laboratory instrumentation including HPLC, LC/MS and other laboratory equipment.
• Be able to read, analyze, interpret, and author testing methods and standard operating procedures.
• Be able to work independently, and to interact with scientific peers in an effective manner.
• Be willing to work extended hours, weekends and holidays when needed.
• The position requires extensive standing. The employee is regularly required to walk, sit, and reach with hands and arms.
• The employee must occasionally lift and/or move up to 50 pounds.