Lab Technical Specialist

  • Contract
  • Cork

Website TPM04751

Summary:
Our client, a biopharmaceutical company located in Cork, requires a Lab Technical Specialist to join their team. The ideal candidate will be responsible for assisting in the effective and efficient running of the method, equipment validation and optimisation operations programs.

Responsibilities:

  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead and participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations and metrics.
  • Deliver technical excellence for a number of analytical transfers, method qualifications, investigations and optimisation studies.
  • Provide in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products.
  • Provide on-going technical support to the site in the area of contamination control.

Qualifications & Experience:

  • M.Sc./B.Sc. qualification (Science).
  • 3+ years’ industry experience working with ELISA/Bioassay in a QC/Analytical role group.
  • High level written and verbal communications with advanced PC skills.
  • Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
  • Knowledge of: Minitab, Softmax Pro, JMP, Trackwise.
  • Project management qualification such as, Project Management Professional (PMP).
  • Evidence of Continuous Professional Development.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.