Career Category

Job Description

• Supporting Amgen drug product analytical method transfers to international government / contract labs as part of Amgen's global sales expansion.
• Management of various aspects of the analytical method transfer process (e.g. tracking of transfer milestones, preparation and approval of analytical method transfer plans and reports and ensuring adherence to transfer requirements).
• Completing subject matter expert data review of International lab method run results where required.
• Providing analytical support for drug product registration/import testing in International labs, through management of the shipment of Amgen reference standards, critical reagent and commercial materials.
• Working collaboratively with other functions within the Amgen network and international labs (e.g. International Quality, Regulatory, Supply Chain and Logistics).
• Support the management team with the visual management board and tracking KPIs for the IAS group.
• Completing process improvement projects associated with the international support function (e.g. creation of SOPs and defining requirements in setup of the IAS function in addition to managing the creation of the associated IT system for running the IAS function).  
• Competent in the use of document management systems such as CDOCS

The successful candidate will:

• Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology or Biotechnology.
• Have at least 3-5 years relevant experience in a pharmaceutical/healthcare Laboratory.
• Be very proficient in the use of Microsoft Word, Excel, Teams etc.
• Have strong technical writing skills.
• Be detail oriented, self motivated with good troubleshooting and problem solving abilities.
• Be a self starter and capable of working on own initiative.
• Strong team work skills.
• Proven track record of meeting deadlines.

Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous