Kelly Scientific is looking for a Manager - Manufacturing Analytical Laboratory.
- Manage the transfer of analytical methods to Neuchatel. In addition, create SOPs, logbooks and all analytical documents needed to maintain high quality standard.
- Manage the analytical team and the daily testing of samples generated by the lab process team (cell culture and purification).
- Responsible for planning, maintenance follow up, annual method qualification and all activities related to analytical lab.
- Manage the manufacturing analytical team
- Method transfer from Quality Control to the Manufacturing lab
- Method qualification
- Installation and qualification of the lab equipment's
- Manage planning (testing, maintenance, annual requalification) and control/reagent stock
- Collects, summarizes, and analyzes data to prepare reports and presentations, as appropriate.
- Write and execute protocols to support process deviation
- Presents the data to a scientific audience (R&D and Manufacturing partners)
- Lead investigation
- Evaluates and implements innovations to deliver better performing solutions.
- Perform routine testing as needed
- Project managment
- PhD or Master in biochemistry, biotechnology or equivalent
- Min of 8 years' experience in pharmaceutical industry, ideally in Quality Control
- Very good knowledge of recombinant protein analytical methods (Activity, ELISA, SDS…)
- Very good knowledge in method qualification
- Strong experience in analytical method transfer
- Good knowledge of quality system (trackwise, LIMS)
- Analytical and problem-solving skills
- Good statistical knowledge
- Work in GMP environment
- Fluent in French and goof level of English
Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva