- Independently performs chemical analysis on commercial raw materials, production intermediates and bulk samples, finished products, process and cleaning validation samples, package samples and components
- Assays are qualitative, quantitative and investigational in nature and are perfumed in accordance with Compendia (e.g. USP), FDA and other regulatory body requirements, standard operating procedures, and approved license requirements
- Results are compared with specifications and documented
- Incumbent is technically independent, able to perform more complex studies, and is recognized by colleagues as a source of expertise
- Interacts with supervisor on overall project goals and at the start and end of studies
- Contributes substantially to the interpretation of results and the design of follow-up studies
- Independently perform analytical testing on raw materials, finished products, intermediates, stability samples, cleaning and process validation samples, and packaging and component samples
- Recognize atypical and out of specification test results, instrument malfunctions and methodology issues and participate in the investigation process
- Reviews and approve data. Performs mathematical calculations, interprets results, records observation (may use Laboratory Information Management system) and prepares technical reports in a timely manner
- Maintains all related records, prepares and records media, buffers, reagents, etc. for analytical analysis
- May assists in coordinating test activities for the group
- Maintains a neat and orderly work area
- Assist with technology and method transfers
- Author, reviews and approves laboratory standard operating procedures
- Issues change controls to improve processes and/or methods as directed by the supervisor
- Assay Studies experience is required (1-3 Years)
- Experience on analytical techniques and practical knowledge of operation of different instruments, such as HPLC, GC, FTIR, ICP, NIR, pH and UV, along with wet chemistry
- Years of experience required above may be from academic lab, but resumes must clearly demonstrate this lab experience
- BS degree in Chemistry, or related scientific field, plus 4 years of experience in a laboratory setting
- MS degree in Chemistry, or related scientific field, with 2 years of experience
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