Cell Therapy Development & Validation Lead (M/F)

Job content

Celyad Oncology is looking for aCell Therapy Development & Validation Lead. The successful candidate will be based in Belgium and will report into the Development & Validation Senior Manager in Mont-Saint-Guibert.

Role:

The Cell Therapy Development & Validation Lead acts as a reference expert at the level of the Company in all aspects surrounding the development, validation, and tech transfer of innovative allogeneic CAR-T cell therapies.

He/She independently designs, plans, and coordinates projects, mentors Scientists and Specialists and generates proposals to meet the corporate strategy

Responsibilities :

• Define, coordinate, plan and control the development, qualification, and validation strategy in accordance with regulatory requirements and cGMP. This includes the strategic and operational Management of projects related to the development, qualification & validation of :

1) analytical methods for raw material, start material, in-process and drug substance/ drug product) testing,

2) raw and starting material,

3) Cell & Gene Therapy production processes,

4) process and analytical equipment,

in close collaboration with R&D and Cell Therapy Manufacturing operational units, Regulatory and Quality teams;

• Support to CAR-T cell product development plan, led by R&D;
• Provide scientific coaching of junior profiles within CTMU validation unit and R&D CMC & Process Development team;
• Provide scientific support to CMC submissions, including scientific writing and revision;
• Define, coordinate, plan, and control Tech Transfer; operational & Scientific Coordination and point of contact of Tech Transfer of Drug Substance / Drug Product manufacturing process & QC testing to external partners, CROs and internally (R&D, Cell Therapy Manufacturing operational units);
• Define, coordinate, plan, and control incremental Process optimizations without impact on the final product;
• Oversee raw & starting materials technical selection and any subsequent custom-made manufacturing at Third Parties
• Data monitoring (analysis, interpretation, and reporting) of clinical manufacturing processes.
• Define, coordinate, plan and control drug product investigations (including batch failures);
• Define, coordinate, revise development, qualification and validation protocols/reports and other documentation related to the development, validation strategy (URS, QRM, CCR,…); active participation to Validation Master Plan;
• Manage SOPs, SOPs associated documents (incl. batch records, work files, checklists) and specifications related to manufacturing process, raw materials, analytical method and process and analytical equipment in line with cGMP;
• Budget Management and Control for projects under his/her responsibility.

Qualifications & Experience :

• Education: PhD in Biological sciences or equivalent relevant working experience;
• Strong Knowledge and min 8 years’ experience of pharmaceutical GMP and ATMP;
• Strong Knowledge and min 8 years’ experience in ATMP / bio-analytical, process and raw material qualification / validation;
• Strong knowledge and hands-on experience in CMC submissions and technical transfer;
• Strong Experience with project management and/or management of external activities;
• Immunology or cellular biology background is highly preferred.

Skills & Competencies :

• Highly developed project management and organizational skills;
• Excellent interaction & communication skills, required to work across depts and management levels;
• Leadership attitude, including coaching and mentorship;
• Highly developed writing skills;
• Good analytical and problem-solving mindset;
• Creative and innovative;
• 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),working knowledge of French would be an advantage;
• 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