Director Product Development, Manufacturing and
il y a 3 semaines
**Director Product Development, Manufacturing and Analytical Science & Technology**
**Brussels, Belgium**
**Position Summary**:
The Director Product Development - Manufacturing/Analytical Sciences and Technology, will manage an established team whose responsibilities include the optimization and tech transfer of biologics and small molecules programs to the Brussels Drug Product Fill & Finish manufacturing site. Successful collaborations with external clients, Process Development network, Project Management, QC and Manufacturing will be key. Responsible for the industrial strategies of the site in the Manufacturing Technology area, developing proposals together with the interested functions (Production, Engineering, Quality, Supply Chain and EHS) and implementing them through cost evaluation, identification and implementation of actions aimed at continuous improvement, optimization of production plants and resources used, performance evaluation and supervision of industrialization technical activities in compliance with the regulatory framework in force, the guidelines and the quality and compliance levels established by the GMPs.
The position will direct 3-4 Managers of sub-teams, to drive the facility fit and technical transfer of Drug Product Fill & Finish processes, including the evaluation, alignment and recommendation of equipment/process improvements. The scope of the position includes also Analytical Method Development / Validation, Final Product Visual Inspection and Packaging technologies. This role will also support on-the-floor technical support to manufacturing. The Director will be responsible for supporting the preparation and review of documentation, compiling of process data, and provide technical input in the deviation investigation, change controls, and CAPAs
**The Role**:
- Leads a team of Managers responsible for the effective technology transfer and support of Fill & Finish Drug Product processes for clinical and commercial manufacturing for both internally and externally developed projects.
- Works cross functionally with manufacturing, project management, quality assurance, quality control, supply chain, and facilities departments to create common objectives and ensure right-first-time manufacturing.
- Participates and leads commercial manufacturing transition. Supports process characterization and validation in preparation for commercialization.
- Leads strategic alignment across Catalent Biologics sites and within the Brussels site & works closely with manufacturing to provide on-the-floor technical oversight before and during GMP runs.
- Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.
- Evaluates existing processes and identifies process and/or equipment improvement to enhance efficiency, consistency, and competitiveness within the market. This includes development of project requirements, feasibility, and technical design for implementation into cGMP environment.
- Manages and supports technical documents including batch production records, specifications, project reports, and engineering specifications.
- Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification.
- B.S./B.A. in Biotechnology, or related field, with minimum of 14 years of relevant experience with Drug Product Fill & Finish processes of cGMP biologics/small molecules production
- Prior experience in process development and technology transfer
- Experience in report and documentation skills
- Experience in investigating and closing out deviations, OOS, and CAPAs
- Experience writing and revising standard operating procedures and batch production records
- Experience working on late phase and commercial programs is a plus
**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 hum
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