(Senior) Process Validation Specialist

Gosselies, Belgium

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.

Within our Cell Therapy team in Gosselies (Belgium) there is one position immediately available: Director, Manufacturing Science and Technology (MSAT) in iPSC Cell Therapy. The selected candidate will report to the VP, Cell Technology. We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution.

For more information about the company, please visit our website at www.cellistic.com

The position

The Process Validation (Senior) Specialist reports to the MSAT Director and works fully or partly on-site. He/She acts as a leader of projects related to process scale up, qualification, validation, and tech transfer of innovative cell therapies. He/She independently designs, plans, and coordinates projects to support the corporate strategy.

Responsibilities and duties

  • Coordinate new cell therapy process qualification and validation projects in accordance with cGMP. This includes leasing with Project Managers for the operational management of projects, as well as with the Scientific, Operations and Quality teams.
  • Support executions of experimental plans
  • Coordinate Technical Transfer projects within the cGMP cell production facility from internal stakeholders as well as external clients
  • Coordinate, write and revise qualification and validation protocols/reports and other documentation related to the qualification and validation strategy (e.g., URS, Change Controls, etc.).
  • Establish new SOPs, and SOPs associated documents (incl. batch records, work files, checklists) related to manufacturing process, and process related equipment in line with GMP
  • Support process optimizations and batch failures investigations
  • Support deviations and CAPA related to process development & validation activities
  • Provide scientific support to client CMC submissions, including scientific writing
  • Support data monitoring (analysis, interpretation and reporting) of clinical manufacturing processes
  • Provide process related training of junior profiles
  • Budget management and control for projects under his/her responsibility
  • Work in a constructive and flexible way in project teams

Qualification & Experience

  • Education: Master or equivalent relevant working experience
  • Strong technical knowledge in cell therapy and cell culture with min 5 years’ experience of pharmaceutical GMP manufacturing
  • Min 3 years’ experience in process development or validation
  • Experience with project management and/or technical transfer
  • iPSCs, Immunology, or cellular biology background is highly preferred

Skills & Compentencies

  • Highly developed organizational skills
  • Team player: strong interaction & communication skills, required to work in project teams
  • Highly developed writing skills
  • Good problem-solving mindset. Creative and innovative.
  • Work precisely according to procedures, rules and regulations
  • Flexible mindset capable of dealing with ambiguity and responding quickly, energetically, and enthusiastically to changes
  • Self-motivated, can-do 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

Job Location: Gosselies, 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?

Send your motivation letter with curriculum vitae to: partnering@cellistic.com