Director Process and Analytical Development
il y a 1 semaine
**Location: Gosselies, Belgium**
**Position Summary**:
The Director Process and Analytical Development - Cell Therapy is responsible for leading the P&AD team in the development, GMP translation, and technology transfer and associated analytical methods. The Director is expected to have a comprehensive understanding of Cell Therapy development paradigms for process and analytical development. Driving CMC activities and innovative solutions for early and late-stage client programs is critical for success. The Director is accountable for the operational activities of the P&AD platforms, including ensuring that people and project management process are in place and tracked.
**The Role**:
- Partner closely with prospective and existing clients, as well as Project Management and Business Development, to ensure client expectations, scheduling, and timelines are met.
- Work closely with the Project Management, Quality Control and Operations to ensure successful transfer of processes and analytics from P&AD and/or clients into manufacturing and validations in order to support early phase through commercial manufacturing activities.
- As a key technical leader for Catalent Cell Therapy; identify, assess and implement new process and analytical technologies to improve product yields, quality, success rate, reproducibility and/or reduce cost and time of manufacturing processes
- Serve as a key PD leader and build connections and collaboration across the Catalent network of Cell, Gene, Plasmid and Protein development teams.
- Lead a group of direct reports which may include principal level scientists; people leader reports are expected. Hire, mentor and develop a talented and diverse technical team. Lead team members to engage, improve and reinforce performance of others
- Manage strategic activities across departments and global sites. Define and lead multisite strategic initiatives.
- Other duties as assigned
- PhD in a relevant field, **minimum 10 years in cell and gene therapy**, pharma, or biotech managing a team as Senior Manager on site for at least 2 years or similar experience in a previous role.
- ** At least 10 years' experience in ATMP/Cell and Gene Therapy/Vaccines CMC product development, including process and analytical method development.**
- Experience in preparing regulatory submissions for CMC is a plus.
- Proficient in English verbal and written communication skills to convey and receive ideas and instructions from and to others within the organization.
**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** 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. 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. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.
Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.
Initiative personnelle. Rythme dynamique. Un travail significatif.
Visitez Catalent Careers pour explorer les opportunités de carrière.
Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.
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