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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
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
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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
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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