Operations Senior Project Expert
il y a 4 semaines
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.
As an Operations Project Expert, you will be an integral part of the Operations Project team, driving projects that support the manufacturing operations of our CAR-T manufacturing plant. Your role will ensure the timely readiness of clinical and commercial CAR-T product supply for both Europe and the US. By coordinating multidisciplinary teams, you will manage low-impact projects within a sterile cGMP/ATMP environment, focusing on process optimization, cost reduction, and compliance with quality and safety standards. You will collaborate with various departments, ensuring seamless project execution and alignment with strategic goals. The Operations Project Expert will report to the Operations Senior Advanced Project Supervisor.
What can you expect?
Here's what you'll do:
- Act as an Operational PMO for low-impact projects related to manufacturing operations, QMS (investigations/CAPA/doc updates), IT systems, Training, EHS, and material management.
- Support the design and implementation of facility, equipment, and systems from an operational and business perspective.
- Contribute to Technology Transfer milestones, ensuring operational readiness, execution of Aseptic Process Simulations, Engineering, Stability, and Process Validation runs.
- Develop a robust operational documentation framework, including SOPs, batch records, and work instructions, and oversee training implementation.
- Support audit readiness by performing gap assessments and executing corrective actions.
- Define interdependent project deliverables and ensure timely execution within approved timelines.
- Provide project risk mitigation solutions and guidance to operational management.
- Prepare and manage governance interactions and stakeholder communication plans.
- Monitor and report on project progress, KPIs, and ensure alignment with strategic goals.
Education:
- A Master’s degree in Science, Biotechnology, (bio)-Engineering, Biomedical, Pharmacy, or equivalent education/experience.
- Alternatively, a Bachelor's degree in (bio)-Engineering, Science, Pharmacy, or related field with ≥1.5 years of experience in Operations or within a cGMP/ATMP environment.
Languages: Proficiency in English is required; Dutch is an advantage.
Strengths:
- Strong leadership, teamwork, and relationship-building skills.
- Ability to manage multiple projects, prioritize effectively, and integrate cross-functional issues.
- Excellent organizational, analytical, and problem-solving skills.
- Hands-on, can-do attitude with a focus on continuous improvement.
- Strong attention to detail and ability to work in a fast-paced, dynamic environment.
- Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
- Experience in technology transfers, QMS processes, and production documentation management.
- Strong stakeholder communication and project coordination skills.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
- A meaningful job with an excellent work-life balance.
- A supportive and innovative work environment. We value and encourage learning and personal development.
- The opportunity to work with people from all over the world.
- A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
- Many fun and informal events.
Legend Biotech maintains a drug-free workplace.#J-18808-Ljbffr
-
Operations Project Expert
il y a 4 semaines
Ghent, 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)...
-
Senior Manager
il y a 4 semaines
Ghent, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Senior Manager - Operations Management Consulting, GhentClient:DuPont Sustainable SolutionsLocation:Ghent, BelgiumJob Category:OtherEU work permit required:YesJob Reference:6ea5222ed012Job Views:23Posted:23.01.2025Expiry Date:09.03.2025Job Description:Allow us to introduce ourselves.At dss+, we are not just your...
-
Senior Project Manager
il y a 4 semaines
Ghent, Belgique Itineris Temps pleinThere’s a saying at Itineris: Together goes a long way. And we live by that. Whether your job is translating our customers’ needs into the best software, selling, coding, or keeping our business running smoothly, we’re united by the same mission: growing our company and delivering innovative software that empowers energy and water utilities to engage...
-
BE: Operations Senior Advanced Investigations Supervisor
il y a 4 semaines
Ghent, 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...
-
(Senior) Project Manager
il y a 4 semaines
Ghent, Belgique Ardena Careers Temps pleinAbout UsAs a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio...
-
Operations Project Investigation Lead
il y a 4 semaines
Ghent, 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)...
-
Senior Lead Engineer
il y a 4 semaines
Ghent, Belgique ENGIE Group Temps pleinSelect how often (in days) to receive an alert:Requisition ID: 35345Location: Ghent, BEReady to engineer your positive impact? Then join Tractebel, part of the ENGIE Group, and our 5,600 passionate experts around the globe, driven by shaping a more sustainable world every day. It’s your chance to be a part of the adventure of the century: accelerating the...
-
Warehouse Operations Manager CAR-T
il y a 4 semaines
Ghent, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Warehouse Operations Manager CAR-T, GhentClient:Randstad Professionals BelgiumLocation:Ghent, BelgiumJob Category:OtherEU work permit required:YesJob Reference:2ac349f8ba7aJob Views:24Posted:23.01.2025Expiry Date:09.03.2025Job Description:The Warehouse Operations Manager will be responsible for overseeing, managing...
-
Senior Machine Learning Consultant
il y a 4 semaines
Ghent, Belgique Möbius Business Redesign Temps pleinMöbius is een toonaangevend adviesbureau dat organisaties in zowel de publieke als private sector begeleidt bij het ontwerpen en implementeren van oplossingen voor complexe strategische uitdagingen. Onze expertise ligt in het vertalen van innovatieve strategieën naar concrete resultaten. Om deze transformatieve oplossingen te realiseren en onze impact nog...
-
Director Integrated Infrastructure Projects
il y a 4 semaines
Ghent, Belgique ENGIE Group Temps pleinSelect how often (in days) to receive an alert:Director Integrated Infrastructure ProjectsRequisition ID: 2852Location:Ghent, BE, 9000Ready to engineer your positive impact? Then join Tractebel, part of the ENGIE Group, and our 5,600 passionate experts around the globe, driven by shaping a more sustainable world every day. It’s your chance to be a part of...
-
Data & Revenue Operations Lead
il y a 4 semaines
Ghent, Belgique Teamleader CRM Temps pleinRole: Data & Revenue Operations LeadScope:Lead our revenue operations and data analytics to drive efficiency, growth, and alignment across teams, products, and marketsLevel:LeadLocation: Ghent, Belgium or Amsterdam, the Netherlands with a hybrid work modelTiming: ASAPWho are we and why should you care?Teamleader is a SaaS scale-up born in 2012 in Ghent,...
-
Project Manager IT Integration
il y a 4 semaines
Ghent, Belgique Tbwa ChiatDay Inc Temps pleinLegend 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...
-
Operations Manager Food Testing Belgium
il y a 4 semaines
Ghent, Belgique Eurofins Humangenetik & Pränatal-Medizin Temps pleinJob DescriptionIn a nutshell: Are you a passionate leader with experience in operational excellence within the food industry? Do you excel at driving productivity, quality, continuous improvement and managing teams? Are you motivated by the challenge of leading two of our food microbiology laboratories? If so, this might be the role for you!We are looking...
-
Consultant/Expert bodemonderzoek – Alle regio’s
il y a 4 semaines
Ghent, Belgique ABO-Group Temps pleinConsultant/Expert bodemonderzoek – Alle regio’sHome > Consultant/Expert bodemonderzoek – Alle regio’sABO nv is een advies- en ingenieursbureau dat deel uitmaakt van de ABO-Group. De belangrijkste activiteiten van ABO zijn bodemonderzoek en bodemsanering, milieustudies, archeologisch historisch en bouwkundig onderzoek, asbest- en sloopinventarisaties,...
-
Senior .NET Developer
il y a 4 semaines
Ghent, Belgique team.blue Temps pleinCombell is hiring!As the Belgian market leader in hosting services, Combell has become the most reliable one-stop partner for hosting any IT infrastructure, website or application.Combell is part of the international team.blue group. team.blue is an ecosystem of successful brands working together across regions to provide customers with everything they need...
-
Junior Operations Technician
il y a 4 semaines
Ghent, Belgique Legend Biotech Temps pleinDo you have what it takes to become a Legend in innovative and life-saving cell therapies? Then join our pioneering Operations Team, redefining biotech. Here, every day is an opportunity to contribute to the fight against life-threatening diseases. Looking for a meaningful first job? Look no further!What can you expect?The job of a CAR-T Operation Technician...
-
Active Directory Expert
il y a 4 semaines
Ghent, Belgique Sopra Steria Temps pleinSopra Steria offers tailored, end-to-end corporate technology and software solutions to help clients make bold choices and deliver results. Successfully so! With more than 56.000 colleagues in 30 countries, we rank as Europe’s leading digital solutions provider. Some of the most successful companies in Europe rely on our technology due to our commitment to...
-
Senior Embedded Software Design and Development Engineer
il y a 4 semaines
Ghent, Belgique Daikin Qatar Temps pleinSenior Embedded Software Design and Development EngineerJob Category: Research and DevelopmentLocation: Gent, East Flanders, BEJob Requisition ID: 1439Daikin Europe is hiring a Senior Embedded Software Design and Development Engineer in Ghent.As a senior embedded software design and development engineer, you will acquire deep technical knowledge of the...
-
Operations Graduate Program
il y a 4 semaines
Ghent, Belgique AB Volvo Temps pleinOperations Graduate Program - Logistics Automation EngineerLocation: Oostakker, BE, 9041Position Type: GraduateTransport is at the core of modern society. Imagine using your expertise to shape sustainable transport and infrastructure solutions for the future. If you seek to make a difference on a global scale, working with next-gen technologies and the...
-
Operations Graduate Program
il y a 4 semaines
Ghent, Belgique Adecco Belgium Temps pleinUnlock Your Future in Operations & Digital TransformationAre you ready to shape the future of operations and logistics? Join this Graduate Program and be part of a dynamic, technology-driven environment where innovation meets impact. Over 15 exciting months, you’ll gain hands-on experience in cutting-edge manufacturing, automation, and digital solutions...
