Cell Therapy Process Development Engineer
il y a 2 jours
Sangamo Therapeutics France
**_Cell Therapy Process Development Engineer (H/F) (Experienced)_**
**Titre**:Cell Therapy Process Development Lead Engineer (H/F)
**Département**: Pharmaceutical Development
**Localisation**: Valbonne, France
**Manager**: Director, Cell Therapy Technical Development
**Job Summary**:
**Essential Functions**:
- Identify and implement relevant up to date technologies for successful manufacturing of cell therapy products
- Provide process expertise in at least one of the areas of cell isolation, expansion, purification, transduction/transfection, cryopreservation
- Familiar to statistical tools and DOE approach to support process development
- Conduct/Analyze in process controls to support process development activities (mainly phenotypic analysis, cellular assays that indicate cell functionality)
- Lead, review and/or assist in writing and revising technical documents including laboratory SOPs, study protocols and reports
- Collaborate with Analytical Development, Research, MSAT, Manufacturing and Quality as well as external partners to design,
- Participate to the implementation of GMP-compliant cell therapy manufacturing process.
- Provide Subject Matter Expertise during Tech Transfer to internal or external manufacturing teams and provide training and technical support.
- As SME and in collaboration with MSAT/QA, support complex deviation investigations to ensure timely resolution and support GMP batch release
- Manage and develop direct reports
**Education, Experience and skills requirements**:
- Ph.D. or M.Sc or Engineer degree in Immunology, BioChemical Engineering, Cell Biology, Biological Sciences, or Biochemistry, or related life science disciplines with 5+ years industry experience.
- Experience in process development of mammalian cell lines or primary cells, preferable within the field of cell and gene therapy in the biopharmaceutical industry
- Preferable experience in manufacturing of cellular therapies including cell separation, cell processing, gene editing, and cell culture techniques for primary cells. Experience with cell base assays, immunoassays, FACS analysis & practices is a real “plus”,
- Must have a solid understanding of process development activities from early stage up to technology transfer. Including knowledge of the relevant regulatory guidelines regarding process development
- Good statistical and DoE knowledge used in process development
- Relevant skills include experience with management of small teams and lab workers
- Excellent written and oral communication skills. Ability to acquire knowledge quickly.
- Ability to work independently and to participate in cross-functional teams, meet deadlines, and organize and prioritize work
Type d'emploi : Temps plein, CDI
Salaire : 22 663,77€ à 56 702,75€ par an
Avantages:
- Participation au Transport
- Titre-restaurant
Horaires:
- Travail en journée
Rémunération supplémentaire:
- Primes
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