Principal) Cmc Technical Development Leader

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

We are seeking an experienced and dynamic Principal CMC/ Technical Development Leader (TDL) to spearhead technical development projects for New Chemical Entities (NCEs), create robust products, and lead cross-functional teams.

If you have a strong background in science, a track record in pharmaceutical drug development (NCEs), 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 CMC project leader, you will be responsible for the fast and efficient execution of the CMC part of our NCE development projects resulting in robust processes and products as well as complete CMC technical packages, while ensuring successful scale-up of the finished product and global regulatory approvals.
- You will contribute to a scientifically sound and business driven technical strategy, in line with overall project strategy, Global Project Leader (GPL), functional experts and managers.
- Additionally, you will work globally and cross-functionally (e.g. with Clinical, Marketing, Regulatory) as the leader of Technical Development Teams for NCE Development projects. You will also contribute to Research projects and ensure smooth transitions to Development.
- You will drive the identification of strategic risks related to the technical development plan, regularly conduct risk assessments and ensure development of mitigation strategies and contingency options.
- Furthermore, you will manage the relationship between Development and Operations to ensure a seamless hand-over of assigned projects as they move from development to industrialization.
- Finally, you will ensure the alignment with the functional heads within and facilitate best practices and alignments across the Development organization.

**Principal CMC Technical Development Leader (TDL)**:

- As Principal CMC TDL you will formulate scientifically sound and business driven technical strategies, in line with overall project strategy, Global Project Leader (GPL), functional experts and managers.
- Also, you will have the capacity to lead or coach junior CMC TDLs.

**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 of NCEs
- 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)
- Excellent interpersonal skills and communication skills
- Strong decision making skills with the ability to solve problems

**Principal CMC Technical Development Leader (TDL)**:

- Many years of experience in pharmaceutical drug product development of NCEs
- Proven track record of leadership of multi-disciplinary project teams demonstrating the ability to lead without authority
- Proven track record of efficient interacting with commercial manufacturing organizations
- Comprehensive and in-depth knowledge of regulatory agency requirements

**Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting in the period from January 31st until February 12th
Step 3: On-site interviews on March 5th and 6th