This role shall report to the Analytical Functional Manager and the main duties & responsibilities shall be:
- Project Management of routine batch release testing in the Analytical Services Department
- Generation of GMP compliant SOPs, Protocols and reports.
- Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
- Receipt and processing of test samples in LIMS
- Carry out data calculations ,basic statistics and trending.
- Assist in internal, regulatory and client visits/audits and respond to findings.
- Carry out test method procedures like generic ELISA, MAT assay, microplate assays or client specific immunoassays.
- Safe and compliant disposal of all laboratory generated waste.
- A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in project management essential.
- BSc/M.Sc. in a relevant science discipline (e.g. Analytical Chemistry)
- Experience in analytical techniques/immunoassays desirable but not essential.