Qc Laboratory Lead
il y a 5 jours
**Exothera** is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vectors 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.
We work every day on reinventing biomanufacturing processes and develop or integrate the next innovative technologies. With the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Jumet, you will join a collaborative team, full of passionate change-makers. You will be a key member of an international and dynamic team in a fast-growing and innovative organization of 150+ people, fully supported by prominent investors and international organizations.
**_
MISSION_**_:_
The **_Quality Control Laboratory Lead_** is in charge of organizing and coordinating day to day laboratory work in the QC organization. The QC Laboratory Lead will make sure that customers project actions and deadlines are integrated in the QC micro planning. He/She will collect, and analyze client needs through project meeting, and develop strategies to optimize operations accordingly.
**_
RESPONSIBILITIES:_**
- Coordinate on a continuous basis the daily planning of the QC lab technicians and scientists.
- Coordinate on a continuous basis the analytical throughput of the lab, i.e. the progress in the testing of the samples.
- Ensure use of the tools to visualize and track the daily planning of the operators and the sample throughput (from sample reception to testing), perform double check when required.
- Act as coach and soundboard for QC lab technicians and scientists, making sure they can execute their operational duties efficiently.
- Work closely with the other QC leads and QC Managers to ensure that the project milestones are reached on time
- Ensure organization’s quality control procedures are respected, ensuring efficiency and smooth workflow.
- Ensure planning adherence; non-conformities follow up and risks/issues escalation to Laboratory Manager. Furthermore, a quality control lead must monitor the progress of teamwork, resolving daily issues promptly and efficiently while adhering to the company’s policies and regulations.
- Participate to internal and external project meetings.
- Make sure that customer project actions and deadlines are integrated in a QC daily planning.
- Work closely with the other QC leads and QC Managers to ensure that the project milestones are reached on time.
- Actively participate to authorities and customers audites as an expert on the floor.
- Follow up the deviations and OOS investigations, supported by the operators.
- Set up or improve the tools to visualize and track the daily planning of the operators and the sample throughput (from sample reception to results reporting into CoA)
**_
REQUIREMENTS & QUALIFICATIONS:_**
- Degree in life sciences / chemistry / chemical or bio engineering (MSc or PhD), or equivalent, with the required skills, knowledge and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities
- Excellent analytical skills, pragmatism, and positive critical thinking.
- Resilience and agility in a demanding and fast-moving environment.
- Planification/Scheduling
- At least three years of experience in a GMP quality control lab environment focusing on analytics of biomolecules.
- Analytical experience with viral particles, viral vectors, vaccines, and monoclonal antibodies is highly recommended.
- Demonstrated experience with analytical method development and validation is required in preferably.
- Experience with Customer interactions, such as in a CRO or CDMO is an asset.
- Fluent in English & French
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