QUALITY UNIT DIRECTOR – GMP Facility (M/F)

QUALITY UNIT DIRECTOR – GMP Facility (M/F)

Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies based on gene-edited T-cells (UCART). By capitalizing on its 18 years of expertise in gene editing – built on its flagship TALEN® technology and pioneering electroporation system PulseAgile – Cellectis uses the power of the immune system to target and eradicate cancer cells.

Using its life-science-focused, pioneering genome engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets.

Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com

Job description

We are seeking for a highly motivated individual to join us as a Quality Unit Director. The successful candidate will work as part of the Pharmaceutical Compliance team of Cellectis Paris and will be responsible for the set up and management of the Quality Management System for a new GMP compliant facility in Paris dedicated to manufacture of GMP/High Quality Grade Raw and Starting Material (Plasmids, mRNA, Viral Vectors).

He/She will set-up the infrastructure, tools and QA team supporting the manufacturing and analytical activities for this project by the review and approval of quality-related documents. He/She will also line manage the Quality Control Director and advise on the QC activities.

In addition, and importantly, the Quality Unit Director will be the key driver to establish a quality culture within the company.

Skills requirements

  • Strong and current knowledge of cGMP compliance and strong cGMP Compliance in the activities of the CMC function, related to cell and gene medicinal products.
  • Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions.
  • Proactively identifies and addresses potential QA problems related to the successful delivery of CMC service.
  • Strong leadership/team management skills and experience.
  • Credible and confident communicator (written and verbal) at all levels.
  • Strategic thinker with the ability to influence at a senior level.
  • Highly customer focused.
  • Excellent project management skills.
  • First class presentation skills (written and verbal).
  • Hands-on approach, with a ‘can do’ attitude.
  • First class organizational skills.
  • Ability to prioritize, demonstrating good time management skills.
  • Highly Desirable: Knowledge of pharmaceutical and/or biotechnology principles

Qualifications and training requirements

  • Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
  • Eligibility to be a Qualified Person in accordance with directive EC/2001/83 is a plus.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Knowledge in Cell and Gene Therapy, specifically Plasmids and Vectors for use in licensed medicines.

Localisation

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