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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Celyad Oncology is looking for a Regulatory Manager. The successful candidate will be homebased in The United States (East Coast) and will report into the Regulatory Affairs Senior Manager in Belgium.

Role & Responsibilities

• Regulatory Lead for assigned Celyad Oncology CAR T cell pipeline projects
• Develop and implement innovative global regulatory strategies for assigned projects
• Provide guidance to team on Regulatory CMC, Nonclinical and Clinical topics
• Develop detailed regulatory project plans and timelines for assigned projects; identify critical path activities, risks, gaps and mitigations
• Organizing meetings, coordinate discussions and capture minutes as assigned
• Manage regulatory submissions and rapid responses to Health Authority questions according to required timelines; coordination with internal and external collaborators
• Effective communication of regulatory strategy and submission status to stakeholders
• Liaise with individual contributors and Subject Matter Experts to develop key messages and complete regulatory submission documents
• Write, prepare and review well-organized, scientifically sound regulatory documents
• Ensure accuracy, consistency, completeness and adherence to applicable requirements of regulatory submission documents
• Format submission-ready documents to meet eCTD publishing requirements
• Track submissions, archive correspondence, maintain regulatory documentation and ensure filling and maintenance of regulatory tracking tools
• Maintain knowledge of current regulatory landscape and competitive intelligence
• Review and interpret regulatory, clinical, scientific and other technical documents
• Represent Department at team meetings as assigned
• Represent Company as liaison with Health Authorities
• Mentor RA staff and cross-functional team members as needed
• Follow policies, procedures and checklists for submission processes and archiving
• Contribute to new internal documentation, SOPs and checklists as assigned
• Additional support with department and company objectives as assigned

Qualifications & Experience

• Masters in Pharmaceutical/Life Sciences with minimum 5 years in a biopharma regulatory role; or PhD in Pharmaceutical/Life Sciences with minimum 3 years in a biopharma regulatory role;
• Expertise in Immuno-Oncology and CMC CAR-T Cell Therapy ;
• Experience in eCTD-compliant regulatory submissions;
• Experience working within a Quality Management System (GxPs);

• Knowledge of European, US and International laws, regulations and guidelines for biologics and human cells and tissues

 Skills & Competencies

• Outstanding written and verbal communication skills, excellent attention to detail;
• Good team player, experienced working in matrixed environments.
• Ability to build excellent working relations at all levels with high professional integrity;
• Strong motivation and ability to take initiative and work independently;
• Ability to manage complex projects and organize heavy workloads effectively;
• Flexibility to prioritize workload to meet evolving timelines in fast-paced environment;
• Computer and data processing skills, Microsoft Office Suite expertise;
• Languages: Fluent English (written and spoken), additional languages are an asset;

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

Role & Responsibilities

As a Regulatory Affairs Assistant, you will support all assigned regulatory affairs activities from adequate documentation, tracking, and filing to agenda organization and management:

• Support regulatory submission:
  • Assist in collection of essential documentation required for regulatory submissions and assist in ongoing collection of essential documents throughout submission processes,
  • Assist in documentation formatting,
  • Create printed binders of ongoing submissions when required.
  • Perform Quality Check of submission dossier,
  • Assist with publishing coordination and follow-up.
• Manage filling and maintenance of regulatory tracking tools.
• Manage department’s Archiving:
  • Assist with regulatory e-mails archiving and tracking,
  • Ensure regulatory data is correctly stored in the company’s data warehouse,
  • Assist with periodic review of regulatory files for accuracy and completeness.
  • Perform an overall housekeeping and inventory to ensure all necessary regulatory documents are properly stored.
• Manage regulatory documentation in compliance with international/national regulations and relevant Standard Operating Procedures (SOPs).
• Support regulatory team with different tasks like scanning, storing of training documents, final contracts, logs, etc.
• Support organization of regulatory meetings (internal and external) including agenda, minutes, and logistics.
• Support department’s SOPs and Policies creation, review, and update e.g., create historical, prepare initial draft, review formatting, coordinate review rounds, support comments implementation.
• May act as regulatory affairs’ team central contact for assigned activities
• Other regulatory activities as directed by Regulatory Affairs Management e.g. study tracking invoices
• Support on Process Improvement initiatives related to the department.
• Assist in making travel arrangements for regulatory staff.

Qualifications & Experience

• Bachelor’s Degree in health care, life sciences, or related field with demonstrable related experience in pharmaceutical/biotechnology industry including documentation management experience in a highly regulated environment. Oncology field experience is an advantage.
• Minimum of 2 years of regulatory affairs administration experience.
• Solid experience of electronic and paper document management systems.
• Proficient in common office technology e.g. Microsoft Office Suite tools, teleconferencing, etc.
• Knowledge of international and national (US & Belgium) regulations/guidelines and of the auditing process and compliance requirements in relation to regulatory submissions.

Skills & Competencies

• Strong general administrative skills
• Excellent planning, communication (written and verbal), and organizational skills.
• Ability to handle multiple complex tasks within a given timeline.
• Ability to work in an international team environment as well as independently.
• Hands-on attitude and can-do mentality
• Fluent in English and French and/or Dutch

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Celyad Oncology is looking for a Clinical Trial Associate. The successful candidate will be home based in USA (East Coast) and will report into the Director of Clinical Operations in Canada.

Role & Responsibilities

As a Clinical Trial Associate (CTA), you will support all assigned clinical operations’ activities from adequate documentation, tracking and filing to agenda organization and management:

• Support high-quality Trial Master Files (TMFs). Perform set-up, maintenance and archiving of TMFs
• Assist in collection of essential documentation required for clinical studies start-up and site activation, and assist in ongoing collection of essential documents throughout clinical studies
• Manage documentation of clinical studies in compliance with Good Clinical Practices (GCP) and relevant Standard Operating Procedures (SOPs)
• Support maintenance of clinical studies management tracking tools and trackers
• Support organization of clinical meetings (internal meetings, CRA meetings, Investigators meetings, etc.) including agenda, minutes, logistics
• Act as central contact for clinical operations team for department communication, correspondence, and associated documentation
• Support (or Lead) on Process Improvement initiatives related to the function

Qualifications & Experience

• Bachelor’s Degree in health care, life sciences or related field with demonstrable related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment. Oncology clinical trials experience is an advantage
• Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
• Solid experience of electronic document management system(s) and eTMF
• Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.

Skills & Competencies

• Strong general administrative skills and a minimum of 2 years of clinical studies administration experience
• Excellent planning, communication (written and verbal) and organizational skills
• Ability to handle multiple complex tasks within a given timeline
• Ability to work in an international team environment as well as independently
• Hands-on attitude
• Able to work in an 100% remote based position

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Celyad Oncology is looking for a Clinical Trial Associate. The successful candidate will be based in Belgium and will report into the Head of Clinical Operations in Mont-Saint-Guibert.

 

Role & Responsibilities

Job purpose is to support all activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report:

•  Establish and maintain key clinical operations databases (enrolment, KPIs, material shipments, site contacts, essential documents, etc.)
• Setup and maintenance of Trial Master Files and Investigator Office files
• Manage documentation of clinical studies in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
• Support organization of Clinical meetings (internal meetings, CRA meetings, investigator meetings, etc.) incl. agenda, minutes and logistics
• Act as central contact for the clinical operations team for department communication, correspondence, and associated documentation
• Actively support the CTM and team to :
  • Perform study sites activation
  • Establish & maintain excellent relationship with study sites
  • Ensure study process improvements implementation (i.e. input in SOPs/WI)
• Prepare all external & internal documentation for assigned trials (as per study protocol, SOP’s, and GCP requirements).

Qualifications & Experience

• Bachelor or master’s degree in Biological sciences.
• Relevant experience in research within Biotech/Pharma industry is a plus.
• Relevant experience in standard cellular and molecular biology techniques such as DNA cloning, gene expression analysis, gene transfer (e.g. retrovirus, lentivirus), (primary) cell culture, multi-color flow cytometry and ELISA is a plus.
• Good knowledge of common computer software packages (Windows, MS Office, etc.)
• Good knowledge of English and French.

Skills & Competencies

• Deliver results and commit to achieve challenging objectives
• Self-motivated and enthusiastic personality
• Good planning & organizational skills
• Team player
• Flexibility and can-do attitude
• Problem solving, proactive
• Quality Mindset
• Integrity & Trust

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The successful candidate will be based in Belgium (Mont-Saint-Guibert).

Role & Responsibilities

• Work within a dedicated discovery research team focused upon delivering key readouts from the company’s new technological advances and cutting-edge products that will form the basis of the company’s core research and clinical strategy.
• Design, plan and perform scientific research on early stage immune oncology discovery programs, to design, create, and characterize the next generation of CARs.
• Work on novel, testable hypotheses to expand our understanding of CAR T cell biology and structure/function relationship.
• Generate scientific proposals and resolve key project hurdles with available information from literature and internal experts.
• Actively participate in and be fully cognizant of practical laboratory work involving the core activities of the discovery research group and work closely with technical staff providing guidance in the delivery of the research readouts.
• Develop and maintain a deep knowledge of relevant scientific literature concerning new research and technologies within the scientific field of Celyad Oncology.
• Ensure good traceability of operations, using appropriate records and templates.
• Present data to project group and larger multidisciplinary teams including externally at meetings/congresses/conferences and author publications in peer-reviewed scientific journals.
• Maintain open and effective communication with R&D Scientists and the different departments of the company in collaborative projects through means including reports and presentations.

Qualifications & Experience

• PhD in biological sciences with emphasis on molecular biology or genetics
• Minimum 3 years post-doctoral experience with a publication track record in high quality peer-reviewed scientific journals
• Expertise in molecular biology, cloning, gene expression, retroviral/lentiviral gene delivery and gene editing.
• Experience in immunology (T cell culture, cytokine analysis, proliferation, cytotoxicity) is a big plus.
• Excellent communications skills in English, both written and verbal are required.

 

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.
• Deliver results and commit to achieve challenging objectives
• Problem solving, proactive
• Scientific writing and presentation skills
• Good planning & organizational skills
• Flexibility and can-do attitude
• Integrity & Trust

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

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