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CSCSL Behring

Director, Process Development(m/w/x)

Bern
Full-timeOn-siteSenior

Leading Albumin downstream process development and optimization for biotherapeutics. PhD or Master’s with GMP and regulatory framework understanding required. Well-being support and global biotherapeutics leadership.

Requirements

  • PhD or Master’s in Biotechnology, Biochemical/Chemical Engineering, or related field
  • Strong downstream processing expertise
  • Proven scale-up, tech transfer, and manufacturing support experience
  • Deep GMP and regulatory frameworks understanding (FDA, EMA)
  • Demonstrated leadership and team management experience
  • Preferable understanding of plasma process development
  • Deep technical expertise in bioprocessing
  • Strategic leadership and decision-making skills
  • Strong problem-solving and analytical skills
  • Cross-functional collaboration and stakeholder management
  • Innovation and continuous improvement mindset

Tasks

  • Lead development of Albumin downstream processes
  • Optimize process yield, quality, and scalability
  • Establish critical process parameters and quality attributes
  • Oversee scale-up from lab to pilot and commercial manufacturing
  • Lead technology transfer to manufacturing sites and external partners
  • Ensure process consistency and robustness across scales and sites
  • Provide expertise in biologics production systems
  • Drive innovation and adoption of new bioprocessing technologies
  • Lead troubleshooting and resolution of complex process challenges
  • Ensure compliance with GMP and global regulatory expectations
  • Support regulatory submissions with process development data
  • Act as SME during inspections and audits
  • Partner with MS&T, Manufacturing, Analytical Development, Quality, and Regulatory teams
  • Align process strategies with product and portfolio goals
  • Lead and mentor multidisciplinary teams
  • Manage budgets, resources, and project priorities
  • Build a high-performing, innovative team culture
  • Support process validation and continued process verification
  • Drive process optimization using data analytics and statistical tools
  • Implement improvements post-commercialization

Work Experience

  • 12 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Benefits

Mental Health Support

  • Well-being support
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