Analytical Execution Team Lead

vor 3 Wochen

Bern, Schweiz CSL Behring Vollzeit

**The Opportunity**:
We are looking for an Analytical Execution Lead for the newly formed Analytical Strategy Team. The Analytical Strategy team is responsible for aligning the analytical strategy across projects, supporting the overall analytical strategy, playing an essential role in product development.

As Analytical Execution Lead, you coordinate all analytical work for several product development projects. You will collaborate with global cross-functional teams to drive the analytical strategy. With an advanced understanding of biologics, analytics, product development, and the regulatory landscape, you act as a partner for the CMC team. You coordinate, plan, communicate, and track the work packages required.

**The role**:

- Represent the analytical department in the CMC delivery team across CSL globally. Organize and lead the analytical execution team and establish all necessary analytical sub-teams.
- Write the book of work and establish the analytical budget for the project.
- Support the head of analytical strategy to define a phase-appropriate analytical strategy and interact with regulators.
- Write analytical development plan and establish an integral analytical project plan containing all analytical work packages.
- Coordinate and track all analytical work packages, e.g., product characterization, stability testing, and GMP testing.

**Your skills and experience**
- Ph.D. and extensive experience in a Scientific Field (Biochemistry, Medicine, Pharmacist, Biotechnology)
- Minimum of 5-7 years of relevant industry experience and equivalent experience in a relevant academic environment.
- Experienced in the analytical lifecycle management for biotechnology products and CMC requirements for regulatory filings (FDA, EMA, ICH guidelines)
- Track record in defining analytical strategies and coordinating analytical work.
- Excellent communication skills (English language).
- Demonstrated ability in managing and contributing to highly effective cross-functional teams.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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