Analytical And Validation Laboratory Manager

Offerta pubblicata in data:
Luogo di Lavoro:
For a prestigious company in the pharmaceutical sector, we are looking for a Laboratory Manager.

The Analytical Dev.& Reference Standard Bank Manager is responsible for managing the daily activities of the laboratory, which are focused on the management of the Reference standard Bank, on analytical methods development and optimization, on performing stability and forced degradation studies, on manage analytical troubleshooting activities and to provide support the R&D and corporate projects.
The goal of this role is to guarantee the reliability of the experimental results, the compliance with timelines and the HSE and quality compliance.

Activities, Duties, Tasks and Responsibilities
- To manage the Lab activities related to R&D projects.
- To guarantee technical support to corporate functions (TO, CQM, LCM etc..).
- To guarantee the technical efficiency of laboratories and equipment in terms of validation status and of health and safety procedures.
- To manage the Reference Standard Bank according to the relevant procedures in force.
- To lead the R&D team during Reference Standard Bank CQM internal audit
- To supervise the Lab activities related to the Reference Standard characterization, storage, labelling, shipment and to stability and forced degradation studies of API and formulations.
- To write/review scientific documentation (validation protocols and reports, investigation reports).
- To contribute to the formation and training of the researchers that operate in the lab.
- To support the department manager in the planning and management activities and in the definition of budget and investments.
- To participate in multidisciplinary teams and continuous improvement projects
- To schedule and assign the activities to the laboratory staff, assuring a balanced workload

Professional Experience
- Experience in management of human resources
- Scientific background as analytical specialist.
- Management of R&D and regulatory project.
- Management of troubleshooting activities.

- Master Degree in scientific subjects (e.g. Chemistry, Pharmaceutical Technologies etc..)

Professional knowledge
- Detailed knowledge of the main analytical techniques of the Analytical Dev. & Validation lab (Liquid and Gas Chromatography, spectroscopic techniques etc..).
- Development, validation and transfer of analytical methods.
- Knowledge of the guidelines for RS management and for stability and forced degradation studies.
- Knowledge of the main guidelines for pharmaceutical products characterization.
Inquadramento: Full Time
Offerta di lavoro pubblicata da: Experis