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US: Senior Analytical Chemist

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US: Senior Analytical Chemist
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99887068_Senior_Analytical_Chemist.html
Date: 30-Apr-2015
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

Senior Analytical Chemist

Responsibilities include, but are not limited to:

* Develop and suitably validate analytical methods in support of API and/or drug product manufacture and/or stand-alone analytical projects. * Perform routine analytical testing in-line with project requirements, including: * Stability testing * Testing in support of chemical development activities (process development, protein and peptide technologies & radiolabelling) * Release testing in support of in-house non-GMP and GMP projects as well as release testing for Clinical Services projects * Be trained and be fully competent in the following analytical techniques, as dictated by project and/or departmental requirements, which include: HPLC; GC; NMR; IR; UV; MS; KF and classical techniques * Perform analytical duties right-first-time in order to complete work within the budgeted resource time and in line with agreed timelines. * Prepare, review and approve data and documents accurately and efficiently, in-line with the Analytical Department's procedures culture of Right-First-Time. * Take responsibility for the provision of all analytical activities associated with allocated projects so as to ensure successful project outcomes as measured by QQTE (Quantity, Quality, Timeliness & Efficiency) metrics. * Be responsible for the generation, training and adherence to of analytical documents (e.g. methods, specifications, SOPs etc.). * Allocate work to and supervise analytical chemists/technicians/placement students. * Retain the overall responsibility for the completion of delegated tasks, within agreed budgets and timelines. * Retain an up to date knowledge of analytical techniques and equipment. * Be responsible for the management of own work schedule and provide regular updates to line manager and team members especially with respect to any circumstances that alter agreed timescales and budgets. * Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated. * Ensure that any corrective or preventative action arising from UPDS is completed in full and within allocated timeframes. * Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximize throughput of testing in the laboratories. * Make suggestions for the improvement of efficiency and/or reduction in operating costs within the Analytical Department and the wider company. * Identify incidents of out of specification results and inform the Analytical Team Leader and/or Analytical Manager. * Assist in the generation of specifications and SOPs relevant to the Analytical Laboratories, ensuring that current versions are available. * Deputize for their supervisor's absence in the day-to-day running of projects and supervision of analytical activities being performed in their designated laboratory. * Ensure that laboratory equipment remains in calibration and functions as required. Where this is not the case inform the appropriate persons for them to action. * Ensure that lab and write-up areas are maintained in an audit-ready condition at all times. * Prepare and present analytical data to customers (telecoms, face-to-face meetings etc.)

Required Skills: * Bachelors of Science Degree in chemistry or related field required * A minimum of eight years of previous analytical experience within industry (i.e. pharmaceuticals/fine chemistry) required * A minimum of eight year of experience in HPLC method development and/or validation required * Experience of drug substance or drug product analysis in a GMP/GLP environment preferred * Previous experience within a supervisory role preferred * Basic level ability in the use of Microsoft Packages (Word, Excel etc.) * Excellent communication skills (verbal and written) * Proven ability to apply a meticulous approach to tasks undertaken * Proven ability to organize and plan work both independently and in conjunction with team members


Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/

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