- Title: Scientist - Formulation Analytical Chemist I
- Code: RCI-19125-1
- Location: McPherson Kansas (KS) 67460
- Posted Date: 06/30/2020
- Duration: 12 Months
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- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
- Under supervision, routinely performs formulation, wet chemistry and chromatographic procedures. Generates developmental and GMP data.
- Has a fundamental understanding of GMP and practices.
- Authors protocols and reports. Drafts test methods and specifications.
- Contributes to project team and brainstorming meetings.
- Once appropriately trained, this individual may be designated as a data reviewer.
- Practices outstanding customer service.
- Routinely performs formulation, wet chemistry and chromatographic analysis using appropriate techniques such as HPLC, LC-MS, GC-MS, HIAC, DSC, TGA, KF, FTIR, Dissolution Instrument, etc.
- Develops basic analytical methods with minimal supervision on a variety of techniques and instrumentation.
- Performs method validation by contributing to writing protocols, reports and analytical methods with minimal supervision.
- Fundamentally understands and complies with GMP/GLP.
- Generate, analyze and report submissable data.
- Grasps a general understanding of the breadth and depth of drug development and contributes to scientific discussions during project team meetings.
- With supervision the individual should be able to operate and troubleshoot sophisticated analytical instrumentation while routinely ensuring that it is operating within required performance ranges.
- Understand regulatory guidelines and can author protocols, reports and analytical test methods. They generate and analyze scientific data and handle OOS (Out of Specification) with little difficulty.
- Must be able to generate, collect and analyze scientific data and determine that it meets all requirements for submission. Must maintain accurate and complete documentation.
- Should be able to recognize cause and affect relationships and explain results in scientific terms.
- Has responsibility for planning and conducting lab activities within the bounds of applicable policies and procedures.
- Has responsibility for informing supervisor of suspect data and for subsequent investigation. Results are regularly reviewed in detail with supervisor.
- Bachelor's Degree required. Master's Degree preferred.
- Years of experience is taken to mean relevant to the job function.
- A minimum of a BS and 3 years of experience in a Pharmaceutical company is required.
- MS in chemistry or other closely related field plus 1-2 years of experience in a Pharmaceutical company is preferred.