MSAT Laboratory Manager

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MSAT Laboratory Manager

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Medycyna

As an MS&T Laboratory Manager, you will manage the Team of MS&T Laboratory and coordinate work with the implementation and optimization of the production processes of monoclonal antibodies, active substances (USP and DSP stages). You will be also coordinating activities within the implementation and optimization of analytical methods, analysis of process samples from MS&T or other areas. This position is part of the MS&T team, reporting to the MS&T Drug Substance Head. Your responsibilities

Supervising the work of the new MS&T Laboratory Team.
Substantive support of specialists during the performance of tasks, e.g. implementation of production processes on a reduced scale, methods transfers, analysis of results, optimization, creating plans, reports, instructions and procedures.
Substantive support for teams involved in technology transfers, process transfers on a reduced scale, investigation into deviations and problem solving.
Participation in projects for the transfer and optimization of active substances manufacturing processes.
Supervision and approval of protocols, reports, procedures, instructions, plans and other documents created in the area of MS&T for the benefit of ongoing projects and the internal quality system.

If you have

A minimum of 5 years of experience in managing a team in a research and development or pilot scale process laboratory or analytical laboratory.
Knowledge of a wide range of techniques used in the production of recombinant proteins.
Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good Manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines.
Experience in team management and conducting research and development projects.
Fluent English spoken and written.

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