Director, Analytical Strategy Lead

Vor 4 Tagen

Bern, Schweiz CSL Behring Vollzeit

**The Opportunity**:
We are looking for an Analytical Strategy Lead for the newly formed Strategy Office. As Director of Analytical Strategy, you are responsible for aligning the analytical strategy across projects. You will therefore play an essential part in product development. With an advanced understanding of the regulatory landscape of biologics, you act as a partner for Regulatory Affairs, the CMC- and Quality teams. With your significant experience and track record in developing analytical strategies, you will implement aQbD, analytical development plans, analytical control-, comparability
- and characterization strategies. You have extensive scientific knowledge of biologics and an in-depth understanding of analytical methods. You will enjoy a high level of autonomy and accountability with the opportunity to engage and influence stakeholders across the organization. You will have a chance to shape the new Strategic Office and positively impact patients’ lives.

**The role**:

- Provides high level scientific expertise and guidance in the field of Analytical Strategy
- Collaborate with CMC and the dedicated project representatives to implement a consistent analytical control strategy across all projects.
- Collaborate with Quality and CMC to implement analytical aQbD.
- Collaborate to define a state-of-the-art comparability strategy.
- Collaborates with R+D Quality to define the compliance strategy.

**Your skills and experience**
- Postgraduate degree (preferably MSc or PhD) in a Scientific field (Biochemistry, Medicine, Pharmacist)
- Minimum of 8 years' relevant industry experience, preferably in a pharmaceutical or Biotech environment with a high level of expertise of the Regulatory Affairs environment (worldwide knowledge like FDA, EMA)
- Track record in defining Analytical Strategies and implementing aQbD.
- Excellent communication skills (English language).
- Demonstrated ability in 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.

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