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.
- 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 firstname.lastname@example.org.