Celyad Oncology est à la recherche d’un Technicien de Maintenance, qui sera basé à Mont-Saint-Guibert et qui rapportera au Facility Maintenance & ICT Manager.

Rôle & Responsibilités

• Calibration, maintenance préventive et prédictive des équipements et de l’infrastructure dans des environnements cGMP et non-cGMP, y incluant des installations mécaniques, électriques, tuyauteries, et autres systèmes de contrôles ; ainsi que les équipements process/labo/utilités.
• Dépannages et réparations des problèmes d’équipements et d’infrastructure.
• Suivi et surveillance du travail des prestataires de services externes.
• Support à l’installation, au commissionnement et à la validation des nouveaux équipements.
• Planification des interventions avec les équipes internes concernées.
• Définition, en collaboration avec les utilisateurs finaux, de la stratégie de maintenance des équipements.
• Vérification régulière des équipements opérationnels.
• Revue et suivi des pannes, et recommandations en vue d’accroitre la fiabilité sur le long terme.
• Gestion des pièces de rechanges.
• Participation au service de garde.
• Participation au suivi des tâches liées au système qualité (QMS), incluant l’initiation et l’exécution des CCR, CAPA et autres déviations.
• Participation au workflow des qualifications et validations d’équipements (URS, QRM, DQ, IQ, OQ, PQ).
• Gestion des SOPs, des documents associés aux SOPs et des spécifications des équipements, en conformité avec normes cGMP.
• Complétion rigoureuse de la documentation GMP.
• Classement et archivage des documents liés au département Infrastructure.
• Maintient permanent de la sécurité (« safety ») et de l’ordre et la propreté de l’environnement de travail.
• Support aux initiatives d’amélioration continue.
• Support aux autres tâches du département Infrastructure.

Qualifications & Experience

• Bachelier en mécanique/électricité/instrumentation ou autre discipline similaire, ou expérience dans une fonction similaire.
• Certification BA4.
• Minimum 3 années d’expérience dans l’industrie pharmaceutique.
• Minimum 3 années d’expérience en qualification, calibration et maintenance d’équipements cGMP.
• Expérience opérationnelle acquise sur des équipements et systèmes de contrôle requis dans un environnement cGMP, tels que : HVAC, électricité, tuyauteries, équipements de laboratoire, maintenance générale, intérieure et extérieure.
• Compréhension du système qualité pharmaceutique

Compétences & Abilités

• Lecture et compréhension des schémas électriques, mécaniques, hydrauliques, pneumatiques et P&ID.
• Connaissance des systèmes électriques, mécaniques, HVAC, hydrauliques et pneumatiques.
• Capacité avancée de dépannage d’équipements en milieu pharma.
• Capacité à gérer les priorités et travailler dans l’urgence.
• Flexibilité et autonomie (travailler avec un minimum de supervision) dans un environnement « biotech » qui change fréquemment.
• Capacité à interagir avec des prestataires externes.
• Précis et méticuleux.
• Soucieux des détails, de la qualité, et de la conformité.
• Bon communicateur et esprit d’équipe
• Proactif et orienté client (interne)
• Capacité physique à intervenir dans tout type de conditions (se tenir debout longtemps, marcher, s’accroupir, se baisser, grimper à une échelle, etc.).
• Langues : français courant avec un niveau intermédiaire d’anglais (niveau B1).

 ___________________________________________________________________________________________ Celyad Oncology is looking for a Maintenance Technician. The successful candidate will be based in Belgium and will report into the Facility Maintenance & ICT Manager in Mont-Saint-Guibert.

Role & Responsibilities

• Perform calibrations, predictive and preventive maintenance of equipment & infrastructure systems in both cGMP and non-cGMP areas. This includes building systems, mechanical systems, electrical systems, plumbing systems, control systems and process/lab/utility equipment.
• Troubleshoot and repair equipment & infrastructure problems.
• Monitor the work of contracted suppliers and service providers.
• Support installation/commissioning/validation of new equipment/infrastructure.
• Plan equipment downtime with internal customers.
• Define in collaboration with end users the maintenance strategy for all equipment.
• Perform operational equipment checks.
• Review and track equipment failures and help make recommendations for increased long-term reliability.
• Manage spare parts.
• Participate in the Maintenance on-call responsibilities.
• Participate in the follow-up of QMS-related tasks, including initiation and execution of CCR, deviations/events and CAPA’s.
• Participate in the equipment qualification and validation workflow (URS, QRM, DQ, IQ, OQ, PQ).
• Manage SOPs, SOPs associated documents and specifications related to infrastructure equipment in line with cGMP.
• Complete diligently all GMP documentation.
• Filing and archiving of Infrastructure Dept documentation.
• Maintain safe working environment and good housekeeping at all time.
• Supports continuous improvement initiatives.
• Support any other tasks within the department scope as assigned.

Qualifications & Experience

• Bachelor’s degree in Mechanical/Electrical/Instrumentation or other relevant discipline or working experience.
• BA4 certified.
• Min 3 years experience within the pharmaceutical industry.
• Min 3 years hands on experience in qualification, calibration and maintenance of cGMP equipment.
• Demonstrated understanding of equipment and control systems needed to run a cGMP facility such as: HVAC, electrical, process systems, plumbing/piping, process and lab equipment, general maintenance, both interior and exterior.
• Understanding of Quality Management System.

Skills & Competencies

• Ability to read & understand electrical, mechanical, hydraulic, pneumatic and P&ID drawings.
• Knowledge of electrical, mechanical, HVAC, hydraulic and pneumatic systems.
• Strong troubleshooting skills.
• Able to prioritize multiple task/priorities and the ability to work under specific time constraints are required.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to interact with suppliers and external contractors.
• Focus on quality, compliance and detail.
• Work precisely per procedures, rules, regulations and planning.
• Good interaction & communication skills.
• “Can do” attitude and willingness to put internal customer needs first.
• Languages: excellent level of French and intermediate level in English (B1 level).
• Must be able to stand, walk, squat, bend, kneel, climb.
• “Safety first” attitude and compliancy to rules and regulations.

For more information about this position or about the Company, please contact us by email at  job@celyad.com

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Celyad is looking for an R&D Alliance Manager (M/F). The successful candidate will be based in Belgium and will report into Chief Scientific Officer.

Location:

There is flexibility concerning location although it will be important for the role that the successful candidate is able to spend significant time with the R&D Department that is based in Mont Saint Guibert, Belgium.

Role:

The R&D Alliance Manager will play a central role in linking the scientific endeavors of the R&D group with external facing collaborations and partnerships which range from business focused activities through to highly focused scientific collaborations and managing interaction with contract research organizations.
The role will require a deep understanding of the scientific basis of the platform technologies and products that are in development by the company along with acumen for critical business-orientated decision making.

Responsibilities:

The R&D Alliance manager will be expected to take responsibility of managing industrial alliances and partnerships. (S)he will:

• Develop and maintain a broad and deep relation with external partners
• Work closely with R&D scientists and managers to provide a conduit that supports business development activities.
• Maintain updates to the partner of the latest developments of their alliance; develop and execute attainable and strategy plans with the company needs and objectives
• Build multi-level relationships with its partners; produces high-quality leads through constant engagements, meetings and managing where required of the appropriate steering committees and working groups.
• Coordinate with internal resources to achieve partnership goals and objectives.
• Provide feedback to the management on the partnership development, achievement, and challenges.
• Contribute to the monitoring of related scientific technologies or scouting future technologies.
• To actively work with R&D management to provide support with contract research organizations, academia and other scientific / business entities to support the delivery of R&D goals and objectives.

Qualifications & Experience:

• Education: PhD. Expertise within the area of Immunology / Cell Biology / Molecular Biology would be beneficial but not essential.
• Experience in Alliance management and Business development would be beneficial but not essential. Candidates with strong R&D backgrounds and documented strength in external collaborations would be suitable working with our internal Business development to build their business competencies.
• 5 years+ post-doctoral experience either in industry or academia

Skills & Competencies:

• Languages: excellent level English (oral and written). French would be beneficial.
• Excellent organizational and communication skills.
• Strong presentation skills.
• Leadership attitude
• A desire to innovate and to be a problem solver
• Ability to travel

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Celyad is looking for a Clinical Research Associate (M/F). The successful candidate will be based in Belgium and will report into the Head of Clinical Operations in Mont-Saint-Guibert.

Role:

The CRA will strengthen our team within Clinical Operations Department, supporting our many projects. As an experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field of clinical research, you will be a productive member of the team. You enjoy start up, enrollment, follow up and closure of clinical trial activities, and mainly monitoring the progress of clinical studies at the site level.

Responsibilities:

•  Clinical Site Start-up :
  • Support with identification of clinical sites
  • Preparation of packages for ethical committee (EC) submissions
  • Submissions to ECs
  • Preparation of site budget, negotiations of site budget
  • Organization, preparation, performance, follow-up of Site Qualification visits, Site Initiation visits
• Clinical Site Management :
  • Organization, performance, follow-up of trainings
  • Organization, preparation, performance, follow-up of Monitoring visits, Close-out visits
  • Identification, communication, resolution of site-related matters, issue escalation
  • Site leadership
• Development, writing, review of task-related SOPs
• Support clinical supply chain

Qualifications & Experience:

• Bachelor or Master degree in (para-) medical or scientific field
• Involvement in study start-up and EC submissions in at least 2 countries
• At least 4 to 5 years of clinical research experience including monitoring, or in pharmaceutical data management including activities during data base locks, or as a study coordinator
• Experience with oncology in early phases
• Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage

Skills & Competencies:

• Very strong attention to details
• Work precisely as per procedures, rules and regulations
• Objective and analytical
• Planning & Organizing skills
• Team spirit
• Excellent English, French and Dutch knowledge (“trilingual”, oral and written), additional languages are an asset
• Strong communication skills
• Hands-on attitude

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Celyad is looking for a Research & Development Associate Scientist (M/F). The successful candidate will be based in Belgium and will report to the Research & Development (Senior) Manager in Mont-Saint-Guibert.

Role:

He/She will be responsible for the accurate design, planning, execution, and reporting of specific scientific studies geared towards the optimization of new allogeneic CAR-T cell products.

Responsibilities:

• Design, plan, perform and oversee research studies in accordance with the R&D objectives
• Present scientific data within the R&D department
• Ensure accurate internal data reporting including scientific report drafting and reviewing
• Participate in and be fully cognizant of practical laboratory work
• Be proactive at reporting and resolving technical hurdles associated with his/her studies
• Stay up-to-date with the latest scientific progress and technologies within his/her projects
• Ensure compliance of his/her research studies with internal guidelines in regard to data traceability, laboratory ethics and SOPs
• Be aware of regulatory recommendations related to his/her work

Qualifications & Experience:

• Master in biological sciences with emphasis on immunology, cellular or molecular biology
• At least 2 years of relevant experience in research within a Biotech/Pharma company. Experience in immunology and or cell therapy is a plus.
• Molecular biology experience including cloning, gene expression (e.g. qPCR, immunoblotting), gene transfer (e.g. retrovirus, lentivirus) and gene editing
• Expertise in primary cell culture and flow cytometry
• Fluency in English, orally and in writing; good knowledge of French would be an advantage

Skills & Competencies:

• Self-motivated and enthusiastic personality
• Strong ability to work in a team focused upon the delivery of results that support the Company’s objectives
• Result-driven and committed to achieve challenging objectives
• Scientific writing and presentation skills
• Problem solving, proactive
• Excellent planning & organizational skills
• Flexibility and can-do attitude
• Quality mindset
• Integrity & Trust
• Excellent communicator

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Celyad Oncology is looking for an IT & CSV Senior Specialist. The successful candidate will be based in Belgium and will report into the IT Director in Mont-Saint-Guibert.

Role & Responsibilities

Role:

Job purpose is to participate to the creation and implementation of an IT team and organization within Celyad Oncology. The scope of this position is to set up, manage, maintain and troubleshoot technology systems, software, computers, servers and networks.

He/She will also advise and support the company’s business on standard IT aspects and qualification requirements in a GxP regulated environment.

Responsibilities:

• Review diagnostics and assess the functionality and efficiency of systems/network
• Implement IT security measures
• Monitor security certificates and company compliance with requirements
• Offer technical support to company staff and troubleshoot computer problems
• Install and update company software and hardware as needed
• Anticipate and report the cost of replacing or updating computer items
• Manage IT Service and Software providers
• Administrate collaborative and offices tools
• Accountable on IT hardware and software asset management
• Participate to internal and external IT audits
• Train end users on IT procedures and security measures
• Write and update IT procedures
• Participate in Computerized System Validation(s) activities, such as User Requirements writing, Validation strategies, IT Systems verifications
• Management of relationships with stakeholders

• Responsible for Celyad IT infrastructure, more specifically manage day to day qualification activities and network/system segregation between GxP and non GxP
• Participate in IT vendor qualification and validation package assessment
• Follow up vendor activities from IT perspective
• Attend project meetings as IT Expert
• Participate in IT system(s) risk assessments
• Support system(s) change management from IT perspective

Qualifications & Experience

• Education: Master’s degree in computer science / Engineering degree or other relevant discipline or working experience
• Minimum 5 to 7 years working experience in similar roles
• Min 3 years’ experience in Biotech or Pharma industry
• Experience in setting up :
  • Relevant operating systems as windows server
  • Data Base system as SQL Server
  • VMware ESX
  • Collaborative tools as Zoom, Teams, Slack, SharePoint…
  • Security tools
• Working knowledge on website development and security / WordPress
• Understanding of regulatory requirements:
  • GMP, GxP (GCP, GLP are a plus)
  • EudraLex Volume 4, Annex 11 and Annex 15
  • FDA 21 CFR Part 11
  • Data Integrity requirements
  • GDPR
• Experience with Quality Management Systems

Skills & Competencies

• Strong interaction & communication skills
• Team player, cross functional capabilities
• Autonomous & proactive
• Good project management and organizational skills
• Excellent problem-solving and critical thinking skills
• Keen attention to details
• Good writing skills
• Can do attitude and Hands-on approach
• Eager to work in a regulated environment (pharmaceuticals)
• Strong work ethic
• Languages: fluency in English and good level of French (oral and written)

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Celyad Oncology is looking for a Quality Specialist. The successful candidate will be based in Belgium and will report into the Senior Quality Manager in Mont-Saint-Guibert.

As Quality Specialist, you will join a team of 7 people and take responsibility to ensure compliance of Celyad Oncology’s owned systems and core activities.

Role & Responsibilities

• Quality support for Change Controls related to new material/service introduction/change
• Quality subject matter expert for qualification and validation activities related to manufacturing facility/utilities and equipment
• Quality support in process validation and transfer: participate to project team meetings, review protocols, and reports
• Perform new material/service Quality assessment
• Maintain approved supplier/service provider list
• Set-up yearly audit plan for supplier/service provider on a risk-based approach
• Responsible for complaints/claims related to material/service provider issues
• Responsible for supplier/service provider change notifications quality assessment
• Participates to GMP audits of supplier and service providers and write reports, follow-up on CAPAs
• Coordination of risk assessment exercises within the Company
• Document review as per function: SOPs, validation protocols, and reports
• Act as back-up for computerized system validation documentation review
• Provide support to quality team on the quality management system software maintenance.

Qualifications & Experience

• Good knowledge of GMP within the bio-pharmaceuticals environment, preferably in product development
• Experience with qualification/validation activities within manufacturing environment
• Experience with computerized systems validation
• Proficient knowledge of desktop IT applications
• Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage
• Scientific degree in Bioengineering/Industrial Pharmacy/Biomedical Sciences, min. 3-5 years of relevant experience.

Skills & Competencies

• Autonomous
• Taking the lead
• Demonstrated knowledge of risk management tools
• Excellent organizational skills and strong attention to details
• Works precisely as per procedures, rules, and regulations
• Team spirit
• Negotiation skills
• Flexible thinking
• Excellent English and French knowledge (oral and written).

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