Be Operations Expert
il y a 2 semaines
**Company Information**
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). 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**
As **CAR-T Operations Expert**, you will be part of the manufacturing operations team responsible for production of CAR-T products for **clinical and commercial operations** in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. You will **lead and perform multiple units within the CAR-T process operations** (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. You will work in a team based, cross-functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members.
As CAR-T Operations Expert, you need to build and maintain smooth and strong collaborations with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for junior operators on the production floor.
You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
**RESPONSIBILITIES**
As CAR-T Operations Expert, you will direct and be part of the daily CAR-T production in a sterile cGMP environment to support clinical and commercial readiness and supply safety policies, quality systems and cGMP requirements.
You will act as Operational Ambassador to:
- Support building the GMP documentation package to ensure timely execution of production operations per cGMP compliance
- Execute production activities common to manufacture clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill and finish and cryopreservation of cells according to SOPs, batch records and aseptic techniques, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).:
- Work daily in a cleanroom manufacturing environment (Grade A/B/C/D) together with operations personnel on the production floor to provide guidance and perform production tasks as needed to train and help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
- Manage the daily production planning in a routine production flow.
- Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
- Build strong partnerships with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse and Quality to ensure seamless execution of daily production tasks
- Act as Production Expert in the field by training and coaching junior production technicians by i) being their first point of contact for routine operational activities and troubleshooting operational day to day problems and by ensuring that SOPs and good safety practices are followed, and ii) being the second point of contact for production optimizations in collaboration with MS&T team
- Support to Testing and implementation of various manufacturing execution system software (e.g. eLiMS, MES, SAP)
- Support the development of manufacturing processes, participate in Lean & Operational excellence projects, and collaborate with MS&T team to drive continuous improvements and efficiencies within CAR-T Operations.
**REQUIREMENTS / QUALIFICATIONS**
- Bachelor's or Master's degree in Science, Bio-Engineering, Biotechnology, Pharmacy or related field or equivalent experience required.
- A minimum of 3 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
- A minimum of 3 years experience in aseptic techniques in clean rooms
- Prior experience in manufacturing, quality, or engineering is required
- Strong influence and relationship building skills with an emphasis on teamwork
- Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
- Strong analytical, problem solving, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, a
-
Operations Expert
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Operations Expert / Lab Technician, Oost-VlaanderenClient:Randstad Professionals BelgiumLocation:Oost-VlaanderenJob Category:OtherEU work permit required:YesJob Reference:e3262acb5df1Job Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:As CAR-T Operations Expert, you will be part of the manufacturing...
-
Operations Expert
il y a 2 semaines
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a **CAR-T...
-
Operations Expert
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Operations Expert - Biotech - Gent - M/V/X, East FlandersClient:Page PersonnelLocation:Gent, East FlandersJob Category:OtherEU work permit required:YesJob Reference:[Job Reference]Job Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:As a CAR-T Operations Expert, you will be part of the manufacturing...
-
Operations Expert
il y a 1 semaine
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **ROLE OVERVIEW** As **CAR-T Operations...
-
Operations Expert
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinFunctieomschrijvingAls CAR-T Operations Expert maak je deel uit van het team dat verantwoordelijk is voor de ontwikkeling van CAR-T-producten voor klinische en commerciële toepassingen in een gecontroleerde cleanroomomgeving (GMP).Je leidt en voert meerdere eenheden uit binnen de CAR-T-procesoperaties volgens standaard werkprocedures en zorgt voor veilige...
-
Marketing Operations Expert
il y a 7 jours
Gent, Belgique Aikido Security Temps pleinWe’re taking on the crusty global cyber market, the "no-BS" security platform for devs. In the past, only large enterprises needed to worry about security. Today,cybersecurity has become the top concern of 75% of all CEOs, from startups to enterprises. This means more work for developers, who need to become security experts and ensure their platforms are...
-
Operations Project Expert
il y a 4 semaines
Gent, Flandre, Belgique Legend Biotech Temps pleinCompany InformationLegend 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)...
-
Operations Senior Project Expert
il y a 4 semaines
Gent, Flandre, Belgique Legend Biotech Temps pleinCompany InformationLegend 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)...
-
Cybersecurity Expert Lead
il y a 4 jours
Gent, Flandre, Belgique Atcon Global Temps pleinAbout the RoleWe are seeking a seasoned Cybersecurity Expert Lead to join our team at Atcon Global. As a key member of our security operations center, you will be responsible for overseeing IT security operations, managing the SOC team, and coordinating with security engineers. Your primary objective will be to implement effective IT security policies,...
-
IT & Security Compliance Expert
il y a 2 semaines
Gent, Belgique Robert Half Belgium Temps pleinRobert Half Technology Contracting is currently looking for an **IT & Security Compliance Expert (M/F/x)** for a 6 months assignment. Robert Half Technology Contracting is currently looking for an **IT & Security Compliance Expert (M/F/x)** for a 6 months assignment. The company is based in **Ghent.** You will be responsible for the following tasks: -...
-
CAR-T Operations Expert, East Flanders
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinAls CAR-T Operations Expert maak je deel uit van het team dat verantwoordelijk is voor de productie van CAR-T-producten voor klinische en commerciële toepassingen in een gecontroleerde cleanroomomgeving volgens de huidige Good Manufacturing Practice (cGMP). U leidt en voert meerdere eenheden uit binnen de CAR-T procesoperaties (d.w.z. componentvoorbereiding...
-
IT Expert
il y a 1 semaine
Gent, Belgique Recruit4Work S.L. Temps plein**Join Our Team**: Seeking an Experienced IT Professional in Brussels Are you ready for an international career that offers not just a job, but a journey? Brussels, the heart of Europe, is not only known for its remarkable blend of historic charm and cosmopolitan vibrancy but also as a hub for ambitious IT professionals eager to make their mark. Our...
-
Operations Technician
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinFunctieomschrijvingBen jij er klaar voor om het verschil te maken? Als Operations Technician of Operations Expert bij onze klant sta je in voor het vervaardigen van therapeutische producten in een cleanroom. Je rol bestaat uit het uitvoeren van allerhande handelingen, waaronder celkweek, zuivering, aseptische verwerking, vullen & afwerken en cryopreservatie,...
-
B2B SaaS Growth Expert
il y a 3 jours
Gent, Flandre, Belgique 24Flow - shop floor management and production scheduling platform Temps pleinAre you a results-driven sales expert looking for a new challenge? Do you have a proven track record of success in B2B sales?About 24FlowWe are a leading provider of software solutions for shop floor management and production scheduling. Our mission is to empower businesses to optimize their operations and improve efficiency.We are seeking a highly motivated...
-
BE: Operations Senior Advanced Investigations Supervisor
il y a 4 semaines
Gent, Flandre, Belgique Legend Biotech Temps pleinOperations Senior Advanced Investigations Supervisor3 days ago Be among the first 25 applicantsCompany InformationLegend 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...
-
it Expert
il y a 2 semaines
Gent, Flandre, Belgique BOROLEO Temps pleinJoin Our Team: Seeking an Experienced IT Professional in BrusselsAre you ready for an international career that offers not just a job, but a journey? Brussels, the heart of Europe, is not only known for its remarkable blend of historic charm and cosmopolitan vibrancy but also as a hub for ambitious IT professionals eager to make their mark. Our company, a...
-
BE: CAR-T Operations Support Supervisor
il y a 2 semaines
Gent, Flandre, Belgique Legend Biotech Temps pleinAs an Operations Advanced Support Supervisor, you will lead and supervise the support operations team responsible for all production support activities (e.g., Grade B cleaning, Material Transfer, Replenishment, Sterilization) and oversee aspects of the CAR-T process operations (Cryopreservation). Your leadership will ensure safe and compliant manufacturing...
-
Operations Technician
il y a 1 semaine
Gent, Belgique Legend Biotech US Temps plein**Company Information** 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). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an...
-
Operations Technician
il y a 1 semaine
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a **CAR-T...
-
IT Operations Analyst, East Flanders
il y a 2 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:ArcelorMittal is the world's leading steel and mining company, with a presence in 60 countries and primary steelmaking facilities in 17 countries. Our goal is to help build a better world with smarter steels. Steels made using innovative processes which use less energy, emit significantly less carbon and reduce...
