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MSAT Bioconjugates Cleaning Validation Expert(m/w/x)
Defining cleaning validation strategy for bioconjugates manufacturing at a global life sciences leader. Master/PhD in bioconjugation, biotechnology, or related life science discipline required. Relocation assistance provided.
Requirements
- Master or PhD in bioconjugation, biotechnology, chemical engineering, organic chemistry or life science discipline
- Preferred industrial experience in GMP environment (>3 years) in bioconjugation, biopharma manufacturing, BioConjugates or DSP
- Advantageous experience in cleaning validation and with regulatory agencies
- Excellent communication skills
- Proficiency in English and advantageous knowledge of German
- Motivation, creativity, agility and open-mindedness
- Strong team orientation and solution-oriented working
- Eagerness to foster teamwork and inclusion
Tasks
- Define and design the site's cleaning validation strategy
- Ensure scientific robustness and regulatory compliance
- Collaborate with QA and Operations on asset improvements
- Lead cleaning validation campaign preparations
- Author protocols and review FMEAs and QC studies
- Assess deviations and investigations during campaign execution
- Evaluate data against defined acceptance criteria
- Manage all cleaning validation documentation and SOPs
- Maintain the facility and product validation matrix
- Monitor and implement evolving regulatory requirements
- Respond to health authority questions during inspections
- Support batch release and define corrective actions
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- bioconjugation
- DSP
- Mammalian
- Microbial
- Swissmedic
- FDA
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
- Highly collaborative environment
- Teamwork and inclusion
Learning & Development
- Professional development programs
Purpose-Driven Work
- Ethical workplace
Bonuses & Incentives
- Performance-based compensation programs
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MSAT Bioconjugates Cleaning Validation Expert(m/w/x)
Defining cleaning validation strategy for bioconjugates manufacturing at a global life sciences leader. Master/PhD in bioconjugation, biotechnology, or related life science discipline required. Relocation assistance provided.
Requirements
- Master or PhD in bioconjugation, biotechnology, chemical engineering, organic chemistry or life science discipline
- Preferred industrial experience in GMP environment (>3 years) in bioconjugation, biopharma manufacturing, BioConjugates or DSP
- Advantageous experience in cleaning validation and with regulatory agencies
- Excellent communication skills
- Proficiency in English and advantageous knowledge of German
- Motivation, creativity, agility and open-mindedness
- Strong team orientation and solution-oriented working
- Eagerness to foster teamwork and inclusion
Tasks
- Define and design the site's cleaning validation strategy
- Ensure scientific robustness and regulatory compliance
- Collaborate with QA and Operations on asset improvements
- Lead cleaning validation campaign preparations
- Author protocols and review FMEAs and QC studies
- Assess deviations and investigations during campaign execution
- Evaluate data against defined acceptance criteria
- Manage all cleaning validation documentation and SOPs
- Maintain the facility and product validation matrix
- Monitor and implement evolving regulatory requirements
- Respond to health authority questions during inspections
- Support batch release and define corrective actions
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- bioconjugation
- DSP
- Mammalian
- Microbial
- Swissmedic
- FDA
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
- Highly collaborative environment
- Teamwork and inclusion
Learning & Development
- Professional development programs
Purpose-Driven Work
- Ethical workplace
Bonuses & Incentives
- Performance-based compensation programs
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Lonza
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