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CSCSL Behring

Director, Pathogen Safety(m/w/x)

Bern
Full-timeOn-siteSenior

Developing pathogen safety strategies for biotherapeutics, defining virus testing, and overseeing reduction in manufacturing. Postgraduate degree in Life Sciences required. Focus on adventitious agent control in global biopharma operations.

Requirements

  • Postgraduate degree (preferably PhD) in Life Sciences
  • Solid understanding of NPD and LCM in Biopharmaceutical environment
  • Proven track record managing complex projects and strategy development
  • Experience working in cross-functional, multicultural, international teams
  • Strong leadership skills, ability to influence others
  • Agility and leading effective organizational changes
  • Thinking beyond, responding in fast-paced, changing environments
  • Bridge building and proactive cross-business collaboration improvement
  • Excellent communication and presentation skills (English)
  • Change management leadership, adaptability to constant change
  • Strategic thinking, aligning goals with business needs
  • External and strategic focus
  • Excellent decision-making ability with limited information

Tasks

  • Develop and execute pathogen safety strategies for product platforms
  • Define pathogen safety measures for starting and raw materials
  • Establish virus and prion testing strategies
  • Oversee pathogen reduction footprint in manufacturing processes
  • Control adventitious agents’ contamination in manufacturing facilities
  • Deliver end-to-end safety strategies for projects
  • Ensure high-quality safety packages for regulatory authorities
  • Adhere to industry standards and regulatory requirements
  • Provide strategic oversight of pathogen safety measures
  • Monitor emerging industry standards and regulatory frameworks
  • Evaluate intellectual property and support due diligence
  • Co-own and maintain pathogen safety best practices
  • Implement Pathogen Safety by Design framework
  • Lead meetings to track pathogen safety work packages
  • Resolve technical and scientific issues in pathogen safety
  • Define virus/prion reduction targets for spiking studies
  • Communicate pathogen safety strategies to CMC and IPT leads
  • Manage execution of pathogen safety work packages
  • Collaborate with PS Laboratories and PS Support teams
  • Design externalization strategy for pathogen safety measures
  • Track delivery of pathogen safety packages
  • Report progress to IPT as required

Work Experience

  • 7 - 10 years

Education

  • Doctoral / PhD

Languages

  • EnglishBusiness Fluent
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