Director, Drug Product Development, Italy
- PHD certification (mandatory)
- 10 years of experience in pharma industries
- advanced technical knowledge of drug product development
- advanced knowledge of manufacturing, tech transfer and validation processes
- good knowledge of GLP
- excellent problem solving and innovation skills
- strong leadership and negotiation skills
- team working
- good communication skills and ability to interact with different stakeholders
- project management
The incumbent will be responsible for leading and managing the Italian-based Drug Product Development team to enable delivery of robust, cost effective and well characterized products for the manufacture of clinical and commercial vaccine products. The incumbent will establish and maintain strong collaboration and interaction both locally and globally with internal (within DP RD and TRD) and external (Discovery, GIO, Quality, Regulatory etc...) partners and contribute to project plans for delivering the CMC strategy and Project objectives with the right quality and on time. The incumbent will ensure that the content and quality of regulatory submissions meets the requirements in all markets specified by the commercial teams. Successful technology transfer of products to commercial manufacturing sites, process validation and support for the R&D responsibilities for pre-approval inspections will be ensured by the Head, Drug Product Development Italy, for all projects developed at the Italian site.
As the team leader, the incumbent will recruit, develop, coach and lead people to create a high performing team with robust succession plans. The incumbent will build expertise and competencies within the Drug Product R&D function in order to bring the best technical solutions to new vaccine product with minimum complexity, cost of goods and meeting the agreed Quality Target Product Profile.
- Serve as a member of the global Drug Product leadership team, contributing to strategic planning and collaboration across the TRD global network
- Lead and manage to enable delivery of robust, cost effective and well characterized products to meet the Quality Target Product Profile for products assigned to the Drug Product Development Italian team.
- Collaborate effectively with Global Discovery Support and New Technology to use the proof of principle and preformulation information to establish innovative manufacturing technologies, new routes of delivery and innovative drug delivery systems for manufacture of new vaccine drug products.
- Utilize Quality by Design and other advanced methodologies to enable definition of manufacturing processes and product presentations.
- Ensure successful process and knowledge transfer to GMP manufacturing sites for clinical and technology transfer and process validation for commercial products
- Support regulatory filings by providing high quality CMC information to enable product licensure
- Develop, coach and lead associates to create high performing teams with robust succession plans
- Establish and maintain strong collaboration and interaction both locally and globally with internal (within TRD) and external (Discovery, GIO, Quality, Regulatory Etc.) partners
- Contribute to project plans for delivering the CMC strategy and project objectives.
- Direct the toxicology pilot plant as a global resource for Drug Product R&D.
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