Specialist in Raw Material (CDD)

Celyad Oncology is looking for aSpecialist in Raw Material (CDD of 6 months, from September

2021 to March 2022), focused on the scientific & quality management of raw material. The

successful candidate will be based in Belgium in our office at Mont-Saint-Guibert and/or home-

based and will report into the Cell Therapy Manufacturing Unit Director in Mont-Saint-Guibert.

Based in our office at Mont-Saint-Guibert and/or home-based, you will join a collaborative team of
passionate specialists and hands-on operators.

As our Raw material specialist, you work across department boundaries, and in close
collaboration with regulatory, R&D, Quality, QC, production, Supply Chain & Procurement,
Business and CROs.

Scientific and GMP knowledge are essential in this role.



Role & Responsibilities

• Define, coordinate, plan and control the qualification and validation strategy in

accordance with regulatory requirement and cGMP. This includes the strategic and

operational Management of projects related to qualification & validation of Raw material in

close collaboration with R&D (IND enabling, Process dev), CTMU operational unit and

QA.

• Management of CMOs/CROs for the qualification of Raw Material

• Scientific Coordination and point of contact for all matters related to raw material with

external partners, CROs and internally (R&D, CTMU operational unit), in collaboration

with the Supply chain & Procurement Manager

• Follow-up on deadlines and raw material project objectives

• Define, coordinate, write and revise qualification and validation protocols/reports and

• Manage specifications, SOPs, and SOPs associated documents (incl. batch records,

• Provide scientific support to CMC submissions;

• Budget Management and Control for qualification/validation and Tech Transfer associated

projects under your responsibility

• Work in a constructive and flexible way in a team
  

Qualifications & Experience

• Education: PhD Biology or equivalent relevant science or working experience

• Strong Knowledge and min 5 years experience of pharmaceutical GMP or ATMP

• Min 3 years experience in Quality Assurance, bio-analytical or raw material qualification /

validation

• Experience with project and CRO/CMO management

• Scientific background with an in-depth understanding of viral vectors, including regulatory

requirements and GMP operational constraints, are a nice-to-have

• Immunology / Cell & Gene Therapy background is a nice-to-have
  

Skills & Competencies

• Strong project management and organizational skills

• Strong interaction & communication skills, required to work across dept, with CROs and

management levels

• Highly developed writing skills

• Good analytical and problem-solving mindset. Creative and innovative.

• Leadership attitude

• Work precisely according to procedures, rules and regulations

• Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and

enthusiastically to changes.

• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills

• Tenacity to drive issues until resolved and deliver results

• Languages: excellent level of English (oral and written)

• Proficient user of Microsoft Office applications

• Flexibility in schedule and for traveling (max 20%) when necessary

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

About Celyad Oncology
Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and
development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company
is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell
therapy candidates for the treatment of both hematological malignancies and solid tumors.
Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New
York, NY. The Company has received funding from the Walloon Region (Belgium) to support
the advancement of its CAR T cell therapy programs. For more information, please visit
www.celyad.com.