Scientist II

Job Title Scientist II Job Description Business: Pharma Solutions Department: Analytical Development Location: Lexington Job Overview Reporting to the Associate Director, Analytical R&D, the 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 identity. Reporting Structure This position reports to the Associate Director, Analytical R&D Key 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 standards Qualifications: • BS, MS or PhD in Chemistry, Biochemistry or Pharmaceutical Science or related • BS with 2+ years' Pharmaceutical industry experience or similar • Experience working with potent, cytotoxic materials and parenteral drug products preferred • 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 techniques