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Senior Director, Product Development - Cell Therapy (H/F/X)

October 3rd 2022

Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché.

Mission Description

  • Provide technical and strategic department leadership for the timely development of commercially viable and robust manufacturing and analytical processes for site New Product Introductions (NPIs), including technology transfer from the customer, pilot-scale process development, scale-up, and process characterization, with strict attention to timelines. 
  • Provides technical sales support in partnership with Business Development, Business, and Site leaders including customer site visits, proposal development, and project meetings
  • Incumbent will play a critical role with Product Development management and Customers during new product development as a direct contact to ensure consistency with operations and readiness required for new products and technologies
  • Oversee scale-up activities of new products to provide critical client materials (e.g., refence lots), and to ensure commercially viable and robust manufacturing processes and minimize adverse impact on plant operations
  • Support project management as needed to coordinate various phases of tech transfer process for NPI’s, existing products, and new technologies with other departments
  • Provide reports and updates of projects and activities as required for internal, customer and regulatory documentation
  • Provide support and technical leadership for the intra-company and outside 3rd party technology transfers of existing technologies and NPI Commercial / Development Products into the site
  • Other duties as assigned

Candidate profile

  • A Bachelors or Master’s degree is required with concentrated studies in Biochemistry or Engineering (or related field) with a minimum of 15 years of relevant work experience, or a Ph.D. degree with a minimum of 10 years of relevant work experience
  • Significant technical/scientific experience in autologous and allogeneic cell therapy with expertise in multiple cell types (to include CAR-T, TCR, TILs, macrophage, NK and MSC cells as well as inducible progenitor stem cells) considered a plus
  • Candidate must have working understanding of pharmaceutical drug substance and drug product systems, cGMP’s, and regulatory guidance relevant to early and late-stage cell therapy clinical manufacture and testing
  • Strong communication skills (verbal and written), strong presentation skills
  • Experience leading large, global teams with significant experience with production processes and equipment.
  • Experience in contract development and manufacturing is highly preferred.

Offer

Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier.

Contact Details

https://careers.catalent.com/us/en/job/0070445/Senior-Director-Product-Development-Cell-Therapy