Analytical Laboratory Manager na
il y a 1 mois
At Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for all
**Exothera**, a Univercells affiliate,is a Contract Research, Development, and Manufacturing Organization (CRDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company,
**Exothera **provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group.
The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. At Exothera and Univercells, Our mission is to make life-changing therapies available to all.
**MISSION**:
The objectives of the
**Analytical Lab Manager** are to
- ensure operational excellence of analytical workflows and deliverables, for both R&D (AS) and QC analytical laboratories.
- ensure efficient method development, qualification, and routine testing operations, within the perimeter of project budgets and the applicable Quality Management System,
contribute to building and improving the systems and procedures of the labs.
**RESPONSIBILITIES**:
- Manage on a regular basis the planning of the AS/QC lab with scientists.
- Synchronize the GMP release and qualification activities with the QC lab manager to appropriately manage shared resources.
- Manage on a continuous basis the analytical throughput of the lab, i.e. the progress in the testing of the samples and/or the validations that are required.
- Set up or improve the tools to visualize and track the daily planning of the operators and the sample throughput
- Manage the deviations and OOS investigations, supported by the operators.
- Oversee the preparation of URS and support the equipment qualification execution as appropriate
- Make sure that the reference samples are managed appropriately
- Act as the direct line responsible for (Senior) Technicians and (Senior) Scientists.
- Act as coach and soundboard for Lab Technicians and scientists, making sure they can execute their operational duties efficiently
- When needed, represent the lab in business development or project progress meetings with customers, during audits or other ad hoc internal meetings
- Actively contribute to developing thequality systems within thelab
- Participate in continuous improvement by suggesting new processes or procedures to meet compliance objectives and improve efficiency
**REQUIREMENTS - QUALIFICATIONS**:
- Advanced degree in life sciences / chemistry / chemical or bio engineering (MSc or PhD), or equivalent,
- At least four years of experience in a R&D & GMP quality control lab environment focusing on analytics of biomolecules
- At least one year in a line management role
- Analytical experience with mRNA, vaccines and/or monoclonal antibodies is highly recommended
- Demonstrated experience with analytical method development and validation is required in preferably several of the following technical areas: HPLC, ELISA, cell-based assays, qPCR.
- Experience with Customer interactions, such as in a CRO or CDMO is an asset
- Problem solving attitude
- Adaptable to fit with a rapidly changing environment
- Sociable and empathic, yet able to give clear instructions, and positive as well as negative feedback
- Analytical mindset, accurate and precise
- Fluent in French and English
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