Scientist II

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Job Description

Scientist IIBusiness: Pharma Solutions
Department: Analytical R&D (ARD)
Location: Lexington KYJob DescriptionBusiness: Pharma SolutionsDepartment: Analytical R&D (ARD)Location: Lexington KYJob OverviewThe Analytical Scientist II conducts complex chemical and physical testing of pharmaceutical raw materials and finished products. Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength impurities and Structure Directly reports to Associate Director Analytical R&DKey Responsibilities Conducts complex chemical and physical testing of pharmaceutical raw materials packaging components finished products microbiological and stability samples by internally developed and compendial test methods. Executes proficiency in development and transfer/verification/validation of test methods for pharmaceutical raw materials and finished products for strength impurities identity and dissolution by HPLC GC dissolution KF spectroscopy and traditional quantitative analysis utilizing HPLC GC dissolution KF spectroscopy and/or traditional wet chemical testing under general supervision Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions Maintains and troubleshoots analytical instrumentation as needed Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients. Prepares and assists in filing regulatory documents in support of internal projects and may provide communications with outside departments corporate sites agencies and clients. Writes SOPs and other instructional documents Cleans and organizes work area instrumentation and testing materials Maintains the necessary compliance status required by company and facility standardsExperience BS MS or PhD in Chemistry Biochemistry or Pharmaceutical Science or relatedWork Experience BS with 2 years Pharmaceutical industry experience or similar Experience working with potent cytotoxic materials and parenteral drug products preferredCompetencies Proficiency using chemistry and analytical instrumental technologies Knowledge of quality and regulatory requirements in the pharmaceutical industry including pharmaceutical GMPs and descriptive organic chemistry. Demonstrated proficiency approaching in solving scientific problems Proficiency with HPLC GC KF and dissolution techniques Good interpersonal and communication skills (both oral and written) Ability to respond to common inquiries or complaints from customers or regulatory agencies Ability to apply mathematical operations to such tasks as determination of test reliability analysis of variance and correlation techniquesPhysical Demands Must use hands to handle feel reach type or operate objects or controls Frequent sitting talking reading or hearing Frequent walking or long periods of standing bending pushing and pulling Long periods of sitting typing or working at a computer station