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Head of qc support laboratory systems Vacatures in Ghent

Laatst bijgewerkt: 22 uren geleden
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QC Training Specialist and Coordinator

QC Training Specialist and Coordinator

Tbwa Chiat / Day IncGent, Oost-Vlaanderen, Belgium
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.Headquartered in Somerset, New Jersey, we are developing advanced cell therapie...Laat meer zienLaatst bijgewerkt: 22 uren geleden
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  • Nieuw!
QC Training Specialist and Coordinator

QC Training Specialist and Coordinator

Legend BiotechGent, Oost-Vlaanderen, Belgium
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.Headquartered in Somerset, New Jersey, we are developing advanced cell therapie...Laat meer zienLaatst bijgewerkt: 22 uren geleden
Head of Product (Universal)

Head of Product (Universal)

SilverfinGhent
Who we are?Silverfin is a cloud first solution that enables accountants to streamline significant parts of their workload and spend more time on value adding activities. Silverfin solves a very real...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Head of Country (Germany)

Head of Country (Germany)

team.blue GlobalGent, Vlaams Gewest, .BE
Quick Apply
The most trusted digital enabler.Europe and has more than 3,000 experts to support them.Its goal is to shape technology and to empower businesses with innovative digital services.Click here to read...Laat meer zienLaatst bijgewerkt: 21 dagen geleden
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QC shiftlaborant

QC shiftlaborant

MaandagGent, Gent, BE
Met jouw expertise in analytische technieken en focus op kwaliteit lever je een cruciale bijdrage aan het waarborgen van de productnormen. In deze veelzijdige rol voer je diverse analyses uit op een...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
QC Analyst

QC Analyst

EurofinsGhent, Flanders, BE
Eurofins Amatsigroup wishes to expand its team with a.We are looking for a person that reports to the QC Manager of the Drug Product Business Unit. You follow up the quality of a variety of Drug Pro...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Head of Downstream Processing

Head of Downstream Processing

Those Vegan CowboysGent, Oost-Vlaanderen, Belgium
Are you a protein science buff, with a hankerin’ for the fine art of cheese-makin’? Come to Ghent!.The Downstream Processing (DSP) posse at Those Vegan Cowboys is on a mission to corral and purify ...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Head of Strategic Development

Head of Strategic Development

Easyfairs BelgiumGent, Oost-Vlaanderen, Belgium
Je hebt een passie voor events? Je weet mensen te inspireren? En je bent iemand die er altijd helemaal voor gaat? Kom dan aan boord van het snelgroeiende team van Easyfairs Belgium!.Bij Easyfairs g...Laat meer zienLaatst bijgewerkt: 25 dagen geleden
Head of Country (Germany)

Head of Country (Germany)

team.blueGent, BE
Fulltime
European leading company in digital accessibility, focused on making the digital world accessible to everyone.Were looking for a visionary and determined Head of Country to drive our expansion and ...Laat meer zienLaatst bijgewerkt: 21 dagen geleden
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Head of Strategy

Head of Strategy

GRS RecruitmentGent, Oost-Vlaanderen, Belgium
Our client, a prominent Forex Trading company based in Dubai, is seeking a talented individual for the role of Head of Strategy. With a strong presence in the Fintech sector, this private company is...Laat meer zienLaatst bijgewerkt: 10 dagen geleden
Lab Technician QC

Lab Technician QC

SD Worx JobsGent, Gent, BE
€ 20,00 per uur
Fulltime
Voor een toonaangevende speler binnen de petrochemische industrie zijn we op zoek naar één extra QC-laborant.Dit voor een tijdelijke opdracht tot eind maart 2025 met mogelijkheid tot verlenging.Je ...Laat meer zienLaatst bijgewerkt: 26 dagen geleden
Head Of Development

Head Of Development

Gentis RecruitmentGent
Vast
We hechten veel belang aan interne expertise.Ons team bestaat uit gespecialiseerde professionals die intern aanwezig zijn en altijd klaarstaan om jou te ondersteunen. Met een dynamische aanpak en ee...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Head of IT

Head of IT

FoodbagGent, Oost-Vlaanderen, Belgium
Actuele vacatures gerelateerd aan Head of IT - Gent - Foodbag.We zijn op zoek naar een enthousiaste Head of IT & Projects om ons IT team te versterken. Ontwikkelen en implementeren van de IT-strateg...Laat meer zienLaatst bijgewerkt: 20 dagen geleden
QC Lab Technician

QC Lab Technician

EastmanGhent, BE,
Founded in 1920, Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a m...Laat meer zienLaatst bijgewerkt: 14 dagen geleden
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Electrical Systems Support Engineer

Electrical Systems Support Engineer

TN BelgiumGent, Oost-Vlaanderen, Belgium
Social network you want to login / join with : .Electrical Systems Support Engineer, Ghent.Electrical Systems Support Engineer. Job Category : Research and Development.The EMEA Electrics and Controls dep...Laat meer zienLaatst bijgewerkt: 6 dagen geleden
Head of PMO

Head of PMO

Viroclinics BiosciencesGhent, Vlaams Gewest, Belgium
Join Our Team as Head of PMO (Project Management Office).Are you an experienced leader who can build and lead high-performing teams? Do you thrive in dynamic environments and possess a talent for s...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
Head of Food Science

Head of Food Science

CeresGreen BelgiumGENT, Belgium
The lab was originally founded in 2008 and has developed its own microbial platforms to express recombinant human proteins for pharmaceutical use. The scientific staff is therefore highly experience...Laat meer zienLaatst bijgewerkt: 30+ dagen geleden
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Head of Business Development

Head of Business Development

ION Develop DifferentGent, Oost-Vlaanderen, Belgium
Je zet de strategische lijnen uit van het business development team en zorgt voor de juiste focus op de juiste producten. Je assisteert in het succesvol finaliseren van nieuwe acquisities (projectgr...Laat meer zienLaatst bijgewerkt: 25 dagen geleden
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Head of Operations - Cubes

Head of Operations - Cubes

BrukerGent, Oost-Vlaanderen, Belgium
As Head of Operation - Cubes, you’ll be responsible for the production and quality control of CUBES, the modular benchtop nuclear imaging product line of Bruker. This entails managing the entire pro...Laat meer zienLaatst bijgewerkt: 2 dagen geleden
Deze vacature is niet beschikbaar in je land.
QC Training Specialist and Coordinator

QC Training Specialist and Coordinator

Tbwa Chiat / Day IncGent, Oost-Vlaanderen, Belgium
22 uur geleden
Functieomschrijving

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview :

The QC Training Coordinator is a position with training coordination and training responsibilities within QC area, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities :

The QC Training Coordinator has both training coordination and training responsibilities, as the need arises.

Training Coordination Responsibilities :

  • Develops and oversees the planning of the execution, documentation and review of QC IPL and EM trainings in order to meet the qualification needs within the CAR-T QC laboratories in Ghent and to meet the needs for QC-support for manufacturing operations.
  • Closely works together with the QC Supervisors to find solutions to urgent or unplanned training-related problems and sets up a system of standard work for trainings.
  • Keeps close connection with the training department and the QC trainers of the release labs.
  • Closely works together with Supervision, Scheduler and Manufacturing Operations to define the timing of (re)qualifications for visual inspection.
  • Executes training related projects (in collaboration with other QC functions) according to project timelines and resource and materials availability. Presents and reports project deliverables to peers and relevant stakeholders.
  • Acts as the point of contact for the organization of QC trainings in external labs.
  • Supports in the set-up of individual training profiles in Summit for the different functions within the QC-teams in Ghent and in the maintenance and reporting of quality training metrics.
  • Performs training assessments for new and updated procedures.
  • Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for the QC teams in Ghent.
  • Serves as subject matter expert for QC training systems.

Training Responsibilities :

  • Responsible for the completion of QC training related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
  • Performs trainings related to the QC-methods such as but not limited to GMP, GDP, environmental monitoring, elims, visual inspection, etc.
  • Conducts Observation, Side-by-Side and Instructor Led training.
  • Ensures training is completed in compliance with all applicable procedures, standards and GMP regulations.
  • Prepares and maintains training materials and equipment in the Ghent CAR-T QC laboratories.
  • Performs peer review / approval of laboratory data including but not limited to training formbooks and records.
  • Creates, revises and reviews relevant QC documents, SOP’s and WI’s.
  • Performs tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • The QC Training Coordinator is available for other duties and demonstrates willingness to learn new skills as required.

    Qualifications : Education :

  • Bachelor’s or master’s degree in science, Bio-Engineering, Pharmacy, Biotechnology, FBLT, MLT or any other related field or equivalent experience required.
  • Experience :

  • A Minimum of 4 years of relevant experience in a laboratory function within an industrial manufacturing or regulated environment. Experience in a QC lab in a controlled pharmaceutical environment is preferred.
  • Key Capabilities, Knowledge, and Skills :

  • A passion to make the difference in the life of patients.
  • Proven training capabilities.
  • Knowledge of cGMP regulations and FDA / EU guidance related to manufacturing of pharmaceutical products is required.
  • Detailed knowledge of CAR-T QC test methods and related equipment is a plus.
  • Knowledge about elims is a plus.
  • The candidate must be highly organized, responsible and capable of working in a highly regulated environment with a positive attitude under limited supervision.
  • Excellent interpersonal and written / oral communication skills, teamwork oriented. Must exhibit ability to convey information to more junior people within the team in a structured and clear way.
  • Ability to interact with external stakeholders related to training and to build strong partnerships with other departments.
  • Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs is a plus.
  • Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment, while providing clear direction to QC supervisors, QC schedulers, QC analysts and QC support technicians.
  • Ability to pay attention to details and follow procedures.
  • Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint).
  • Fluent in both Dutch and English.
  • Legend Biotech is a proud equal opportunity / affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic / civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

    Legend Biotech maintains a drug-free workplace.

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