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

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 IT qualification requirements in a GxP regulated environment.

Information Technology aspects:

• 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

Computerized System Validation and Data Integrity aspects:

• Participate in Computerized System Validation(s) activities and more specifically:
  • User Requirements writing
  • Validation / qualification / migration strategies per company procedure(s)
  • IT Systems verifications (FAT, SAT, IQ, OQ, PQ) when required
  • Management of relationships with stakeholders
• Responsible for Celyad IT infrastructure:
  • Manage day to day qualification activities for the company IT Infrastructure
  • Write and obtain approval for all qualification deliverables as applicable
  • Technically responsible for network and system segregation between GxP and non GxP
• Participate in IT vendor qualification
• Participate in IT vendor validation package assessment
• Follow up vendor qualification / validation 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

IT:

• 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

CSV & DI:

• 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 an Accountant. The successful candidate will be based in Belgium and will report into the Accounting & Payroll Manager in Mont-Saint-Guibert.

Role & Responsibilities

• Ensures the integrity of accounting information by recording, verifying, consolidating and entering transactions
• Preparing financial analyses and reports
• Support month-end and year-end close process by collecting, analyzing and summarizing account information
• Maintaining and reconciling balance sheet and general ledger accounts
• Direct internal and external audits to ensure compliance (incl. SOx)
• Investigating and resolving audit findings, account discrepancies, and issues of non-compliance
• Assist with tax audits, tax returns and tax forms
• Develop and document business processes and accounting policies to maintain and strengthen internal controls
• Collecting timesheet data and payroll information
• Entering data into payroll database and software program
• Maintaining accurate records of payroll documentation and transactions
• Performing other accounting duties and supporting the Finance Team as required or assigned

 Qualifications & Experience

• Bachelor’s degree in Accounting
• Minimum 5 years of accounting experience
• Mastery of national and international accounting standards
• Strong interest in Belgian payroll and accounting legislation
• Fluency in French and English is highly desired.

Skills & Competencies

• Strong financial analysis skills
• Advanced MS Excel skills
• Experience with ERP
• Strong organizational and stress management skills
• Ability to meet communicated schedules and deadlines
• Team spirit

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Celyad Oncology is looking for a Senior R&D Scientist Process Development. The successful candidate will be based in Belgium and will report to the R&D Process Development Manager in Mont-Saint-Guibert.

Role

The role combines 2 areas of responsibility:

1. The R&D Senior Scientist will participate in the design, supervision, planning and execution of specific scientific efforts geared towards the generation and optimization of new allogeneic CAR-T cell manufacturing processes that would consistently generate high number of cells with the best fitness to attack tumors cells and support the passage of therapies into clinical trials.
2. Secondly, he/she will provide an interface that enables the smooth and positive interaction between R&D and the rest of the company including participation in company-wide programs and project team management, ensuring the efficient co-operation and connection to all teams to achieve the common goal of clinical trial delivery.

 Responsibilities

• Lead and deliver research studies focused upon generating innovative manufacturing processes that increase allogeneic CAR-T cell fitness and yield.
• Manage the testing of new approaches and generate high quality analytical readouts to push further CAR-T cell characterization, and consequently further develop the company’s CAR-T cell therapies portfolio.
• Provide scientific background and feedback on results to the technician(s) assigned to his/her studies
• Generate scientific proposals to resolve key technical hurdles associated with his/her studies.
• Ensure accurate internal data reporting including scientific reports drafting and reviewing.
• Ensure the delivery of work within R&D in line with the department objectives and the efficient cooperation and connection to other departments’ activities, such as Regulatory, Manufacturing and Clinical/Medical teams, to achieve the common goal of clinical trial delivery.
• Initiate and generate ideas based on scientific readings and research, and therefore contribute to research plans and efforts.
• Stay tuned on new scientific literature and maintain knowledge concerning relevant new research and new technologies within Celyad’s scientific field.
• Represent R&D internally (e.g. strategy meetings, research meetings, project meetings and development activities).
• Contribute to and lead upon scientific presentations (peer-reviewed publications, white papers, conference presentation) and collaboration with external stakeholders.
• Collaborate closely with R&D management to generate and implement budgets.
• Ensure that all research studies are compliant with internal guidelines and safety protocols.
• Develop high quality studies to support regulatory filing that underpins the clinical activity of the company.
• Provide scientific guidance and ensure appropriate training of new scientific staff members (and students) by sharing technical expertise.

Qualifications & Experience

• PhD in biological sciences with emphasis on immunology or induced pluripotent stem cells
• Minimum 4 relevant experience in research within a Biotech/Pharma company including process development and/or cell therapy development.
• Expertise in metabolism, cell culture, CAR-T cells, gene transfer (e.g. retrovirus, lentivirus, transposons,…) and/or exploitation of next generation sequencing (e.g. RNA sequencing) is preferred.
• Expertise in primary cell culture and immunological assays (e.g. cytokine release assay, flow cytometry, cytotoxicity and proliferation assays) is an advantage
• Strong scientific and technical background evidenced by high quality peer-reviewed publication record.
• Demonstrable experience with scientific presentations.
• Experience in scientific project management would be an advantage.
• Fluency in English, orally and in writing; working knowledge of French would be an advantage.

Skills & Competencies

• Self-motivated and enthusiastic personality
• Passionate, creative, autonomous and science driven personality
• Strong ability to work in team focused on delivery of results that support the Company’s objectives
• Action oriented, delivers results and commit to achieve challenging goals
• Problem solving & proactive
• Excellent planning & organizational skills
• Flexibility & can-do attitude
• Quality mindset
• Integrity & Trust

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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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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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