Validation Lead

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology, and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to get better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexicty and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.

**The position**:
The Process Validation Lead/Senior Lead reports to the MSAT Director and works fully or partly on-site He/She acts as a reference expert at the level of the Company in all aspects surrounding the development, validation, and technical transfer workstreams of innovative cell therapies including iPSC-derived technologies. He/She independently designs, plans, and coordinates projects, mentors Scientists and (Senior) Specialists and generates proposals to meet the corporate strategy.

**Responsibilities and duties**:

- Define, coordinate, plan and control new cell therapy at scale process development, qualification, and validation strategy in accordance with regulatory requirements and cGMP. This includes the strategic and operational management of projects in close collaboration with the Cell Therapy Innovation team, the Gene Engineering team, and the Operations and Quality teams
- Define, coordinate, plan and control Technical Transfer within the cGMP cell production facility. Act as a technical point of contact for Technical Transfer from internal stakeholders as well as external partners ensuring Operational & Scientific coordination
- Define, coordinate, plan and control at scale process optimizations and oversee batch failure investigations
- Be responsible for reviewing process development, qualification and validation protocols/reports and other documentation related to the development and validation strategy (e.g., URS, Change Controls, etc.). Actively participate to Validation Master Plan
- Provide scientific coaching to more junior colleagues
- Provide scientific support to clients for CMC regulatory filings, including scientific writing and revision
- Data monitoring (analysis, interpretation, and reporting) of clinical manufacturing processes
- Manage SOPs, SOP-associated documents (incl. batch records, work files, checklists) and specifications related to manufacturing process and process related equipment in line with cGMP
- Manage deviations and CAPA related to process development & validation activities
- Support the PMO in budget definition
- Work in a constructive and flexible way in project teams

**Qualification & 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 process development & validation
- Strong knowledge and hands-on experience in technical transfer
- Immunology or iPSC biology background is preferred

**Skills & Compentencies**:

- Highly developed team management and organizational skills
- Excellent interaction & communication skills, required to work in cross department projects, team spirit
- Leadership attitude, incl coaching and mentorship
- Highly developed writing skills
- Good analytical and problem-solving mindset
- 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
- Flexibility in schedule and for traveling (max 20%) when necessary

**Job Location**:Mont Saint Guibert, Belgium

**Position Type**: Full-Time

**Start Date**:Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

**Interested?**: