• Conduct routine chromatographic (HPLC and GC, but primarily HPLC) and wet chemistry testing of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures.
• Assist in the transfer (and troubleshooting, where required) of analytical methods to the QC laboratory as and when required.
• Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in a timely manner. Ensure OOS results are escalated and where relevant FARs are required they are initiated within the required timeline.
• Assist in chromatography and wet chemistry training of other QC analysts
• Review and approve non-chromatographic and chromatographic data.
• Present as subject matter expert during third party inspections as required.
• Support continuous improvement projects such as 6S and lean processes for the laboratory
• Management of QC SOPs, change controls, deviations and IRFs.
• Conduct calibration and maintenance of wet chemistry/chromatography instrumentation.
• Participate in department projects, as assigned by QC Team Leader/QC Manager.
• Perform other duties as assigned.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) in a Science related discipline ( Chemistry, Biochemistry or Analytical science) and 5-7 years of relevant industrial experience. Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential.
• Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.
• Strong technical writing skills.
• Empower and other lab software systems.
• cGMP
• Computer skills (MS Office, Trackwise, Minitab, LIMS).
• Strong analytical skills with excellent attention to detail.
• Strong technical writing skills
• Communication skills both verbal & written with good time management skills.
• Ability to work as part of a team