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US: Senior Analytical Chemist

Date: 30-Apr-2015
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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

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BioTech FYI Center