Associate Director Bioprocess Development for

vor 4 Wochen

Bern, Schweiz CSL Behring Vollzeit

CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. With over 1,400 employees we develop and manufacture plasma-derived therapies at our facilities in Bern to deliver them to patients worldwide.

For our location in Bern, we are looking for:
**Associate Director,** **Bioprocess Development for plasma-de**riv**ed biotherapeutics**

In this position, you will be managing and guiding several teams of scientists and technicians tasked with the development and optimization of robust and scalable processes for the manufacturing of plasma-derived biotherapeutics. Specifically, the current primary responsibility is for delivery of a robust and well-characterized Immunoglobulin manufacturing process achieving higher IgG yields.

In more details, your responsibilities will include:

- Managing Process Development teams with respect to resource planning and staff allocation to multiple projects.
- Providing technical expertise and leadership to the assigned team members.
- Ensuring and supervising scale-up, technology transfer and facility fit assessment of development to commercial manufacturing processes.
- Motivating, training and developing all staff. Hiring and developing talents in line with CSL’s strategic objectives is another important element of this position.
- Generating, reviewing and approving technical reports and regulatory documents for health authority submissions; working closely with CMC Team to ensure that source documentation from Bern PPD is aligned with Quality by Design expectations and “submission-ready.”
- Working closely with Process Engineering on aspects associated with scale-up and tech transfer of the manufacturing process.
- Leading a mechanistic modeling resource and helping to shape a global modeling Center of Excellence for Plasma Product Development.

In addition, you will be responsible for working with senior leadership teams to maintain an environment that fosters team work, collaboration and innovation in addition to transparent and timely communication with others internally and externally. All these elements require strong leadership capabilities along with good interpersonal skills.

Go for it - the following competencies will help you to be successful in this role:

- An academic scientific qualification, e.g. Master of Science or Doctorate in Biochemistry, Biotechnology or related area with more than 10 years in pharmaceutical industrial experience in downstream process development or related fields
- Process engineering experience
- Strong and proven scientific background in protein sciences
- Demonstrated ability in managing highly effective teams
- Experience in working in cross-functional, multicultural and international teams
- Experience in project work and excellent communication and analytical skills
- Strong planning and organizational skills
- Strong working knowledge of ICH Q8 - 11 and other regulatory guidance documentation around quality risk management, Quality by Design and knowledge management.
- Advanced knowledge of biological manufacturing processes and advanced QbD requirements for plasma derived or biologic therapies is preferred.
- Generation of technical assessments and documents for submission to regulatory agencies
- Proven managerial experience within project oriented, multidisciplinary and multicultural environments
- Excellent written and spoken language skills in English
- Knowledge of German is an asset

**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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