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 Departments 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 supervisors 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
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
