Position Summary
The Analytical Chemist III is responsible for performing analytical testing to support the release of drug substance, finished drug products, in-process, and stability samples, with minimal oversight. Additional responsibilities include validating/verifying methods for raw materials and method transfers for drug products utilizing the appropriate analytical technique. Responsibilities also include managing activities with good time management, maximize productivity, supporting the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.
Job Responsibilities
- Validate methods for various analytical techniques.
- Provide analytical scientific and technical expertise to the QC group.
- Draft and review technical documents supporting development and release such as method validation/verification protocols and reports, and testing data sheets.
- Manage and perform analytical testing of samples supporting incoming raw materials, in-process production, finished product and stability samples.
- Utilize and troubleshoot analytical instrumentation such as FTIR, HPLC, GC, AA, ICP and wet chemistry techniques and UV/VIS and have a scientific understanding of these techniques.
- Compile data and perform trending studies on raw materials and drug product.
- Train technicians and other chemists on analytical methods, instruments and documentation specification results.
- Perform method troubleshooting/optimization activities.
- Perform and lead investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
- Provide technical leadership and train technicians and other chemists on analytical methods, instruments and documentation.
- Write, review and update standard operating procedures and department policies as needed.
- Perform all activities in compliance with cGLP/cGMP requirements
- Perform supervisor’s/ lead’s responsibilities in their absence.
- Assume other responsibilities as assigned by area management.
- Serve as SME on large equipment
- May handle hazardous waste as required to dispose of laboratory solutions. Basic RCRA training is required for all employees of the laboratory and continuing RCRA training will be performed on an annual basis. New hires may only handle hazardous waste prior to attending RCRA training if they are under the supervision of a RCRA trained employee. RCRA training will be attended within six (6) months of hire.
- For personnel performing additional hazardous waste activities beyond routine discarding of hazardous waste into satellite containers, additional training is required per Exela procedures and policies.
Experience Requirements
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance’s, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF
- Excellent verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skills.
- Experience with Empower
- Experience with Chromatography
- USP and EP experience
Education Requirements
- Bachelor’s degree in chemistry or related scientific discipline with 5+ years of relevant Laboratory experience, or:
- Associate degree with 7+ years analytical Chemistry experience, Preferably in QC, in the pharmaceutical industry.
