Cmc Technical Development Leader

vor 1 Woche

Frankfurt Am Main, Deutschland BI Vetmedica GmbH Vollzeit

**The Position**:
Seize the opportunity to make a global impact

We are seeking an experienced and dynamic CMC Technical Development Leader (TDL) to spearhead technical development projects, create robust products, and lead cross-functional teams. If you have a strong background in science, a track record in pharmaceutical drug development, and the ability to lead without authority, we invite you to join our team and contribute to the development and launch of new products in Animal Health.

**Tasks & responsibilities**:

- As project leader, you will be responsible for fast and efficient technical development projects resulting in create a robust product and completes CMC technical package while ensuring successful global regulatory approvals and scale-up of the finished product.
- You contribute to a scientifically sound and business driven technical strategy, in line with overall project strategy, Global Project Leader (GPL), functional experts and managers.
- Addtionally, you work globally and cross-functionally as the leader of Technical Development Teams.
- You drive the identification of strategic risks related to the technical development plan, regularly conduct risk assessments, and ensures development of mitigation strategies and contingency options.
- Furthermore, you manage the relationship between Development and Operations in order to ensure a smooth hand-over of assigned projects as they move from development to industrialization. Finally, you will ensure the alignment the functional heads within and facilitate best practices and alignments across the Development organization

**Requirements**:

- Ph.D. or Master’s degree in science with a long term experience of Animal Health product development
- Several years of experience in pharmaceutical drug development
- Expertise in the development of finished products including a high-level understanding of the regulatory, quality and clinical requirements
- Involvement in more than one product developments which resulted in successful products on the market and/or multiple patents filed
- Familiarity with relevant health regulatory agency requirements for new drug product submissions, ideally animal health related experience
- Functional representative in multi-disciplinary project teams, ideally a track record of leadership of such project teams demonstrating the ability to lead without authority
- Very good command of English; other languages such as German or French are beneficial Willingness to travel internationally (up to 20 % of your working time)

**Ready to contact us? **:

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