Chemist I/Lead QC Technician

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Perform data generation/interpretation and chemical analysis of developmental products (Pharmaceutical Analysis), in-process and finished products using various analytical techniques and methods. Provide input on revision of procedures affecting the lab. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (Test Methods, Specifications, SOPs). Provide analytical training to other analysts.? Analyze pharmaceutical dosage forms using wet chemistry methods and multiple complex testing methodologies (such as HPLC, dissolution, spectroscopy). Provide an intermediate level of analytical support for raw materials, in-process, developmental products and finished product testing (release and stability) for conformance to specifications/acceptance criteria. ? Support execution of method development and testing in support of validation protocols.? Provide input for writing and revising laboratory procedures. ? Comply with company, laboratory, and safety procedures.? Provide guidance and training to laboratory employees.? Contribute to a team-oriented, continuous improvement quality process.? Perform routine laboratory maintenance tasks including organization and cleaning of work areas, checking for expired reagents, standards, solutions, chemicals and hazardous waste.? Consistently demonstrate the Shire values in day-to-day activities (Integrity, Excellence in Execution, Teamwork/Communication, Customer Focus, Openness/Innovation, Respect).Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? BS degree in Chemistry or closely related field, with the equivalent of 3+ years experience in a pharmaceutical laboratory setting? MS degree in Chemistry or closely related field, with 1-3 years equivalent experience in a pharmaceutical laboratory setting? Basic knowledge in the use and theory of analytical laboratory instrumentation? Knowledge of HPLC and dissolution testing are required; method development and validation experience a plus.? Demonstrated understanding of laboratory interactions and cGMP/quality control requirements? Must be familiar with cGMP, ICH, and FDA guidance documents such as SUPAC IR/MR, DMF, CTD, etc? Experience with SQL LabWare LIMS, SAP strongly desired? Excellent communication and technical writing skills? Working knowledge of MS Word, Excel, Access and other lab-related softwareApply to Shire