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Approving GMP analytical activities, including validation and technology transfer, for rare disease biopharmaceuticals. Strong GMP understanding and ownership of complex scientific work required. 4-day work week, company car for private use.
Requirements
- Quality-minded analytical professional
- Cross-functional collaboration
- Ownership of complex scientific work
- Structure to complex scientific work
- Strong GMP understanding
- Collaborative mindset
- Motivation to deliver quality medicines
- University degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or similar
- 5+ years GMP analytical work in pharma/biotech
- Analytical method development and validation
- Product specifications experience
- Deviation investigations experience
- Change control experience
- QA supporting QC or QC Coordinator experience
- Broad knowledge of analytical chemistry and bioassays
- Clear and compliant documentation practices
- Professional proficiency in English, written and spoken
- Living Sobi CARE values
- Ability to work independently
- Ability to take initiative
- Ability to make sound quality decisions
- Strong communication skills
- Collaborative, team-oriented approach
- Structured mindset
- Attention to detail
- Commitment to continuous improvement
- English language proficiency
Tasks
- Coordinate and approve deviations, CAPA, and change controls
- Approve GMP-related analytical activities, including validation and technology transfer
- Evaluate and approve CLO performance
- Serve as QA contact for CLOs
- Provide QA for stability studies, approving plans and protocols
- Review and approve extension of expiry dates for critical analytical materials
- Review and approve product specifications
- Support Global Regulatory Affairs / CMC in analytical quality issues
- Represent Global Quality, providing QA analytical guidance for projects
- Manage Quality Technical Agreements with CLOs
- Author, review, and approve SOPs and related documentation
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
- Competitive benefits package
Purpose-Driven Work
- Positive impact for rare disease patients
Not a perfect match?
- Novartis Pharma AGFull-timeWith HomeofficeSeniorBasel
- Sobi
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Approving GMP analytical activities, including validation and technology transfer, for rare disease biopharmaceuticals. Strong GMP understanding and ownership of complex scientific work required. 4-day work week, company car for private use.
Requirements
- Quality-minded analytical professional
- Cross-functional collaboration
- Ownership of complex scientific work
- Structure to complex scientific work
- Strong GMP understanding
- Collaborative mindset
- Motivation to deliver quality medicines
- University degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or similar
- 5+ years GMP analytical work in pharma/biotech
- Analytical method development and validation
- Product specifications experience
- Deviation investigations experience
- Change control experience
- QA supporting QC or QC Coordinator experience
- Broad knowledge of analytical chemistry and bioassays
- Clear and compliant documentation practices
- Professional proficiency in English, written and spoken
- Living Sobi CARE values
- Ability to work independently
- Ability to take initiative
- Ability to make sound quality decisions
- Strong communication skills
- Collaborative, team-oriented approach
- Structured mindset
- Attention to detail
- Commitment to continuous improvement
- English language proficiency
Tasks
- Coordinate and approve deviations, CAPA, and change controls
- Approve GMP-related analytical activities, including validation and technology transfer
- Evaluate and approve CLO performance
- Serve as QA contact for CLOs
- Provide QA for stability studies, approving plans and protocols
- Review and approve extension of expiry dates for critical analytical materials
- Review and approve product specifications
- Support Global Regulatory Affairs / CMC in analytical quality issues
- Represent Global Quality, providing QA analytical guidance for projects
- Manage Quality Technical Agreements with CLOs
- Author, review, and approve SOPs and related documentation
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation
Family Support
- Work/life balance
Informal Culture
- Collaborative and team-oriented environment
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
- Competitive benefits package
Purpose-Driven Work
- Positive impact for rare disease patients
About the Company
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Not a perfect match?
- Novartis Pharma AG
Analytical Expert (Postgraduate Early Talent Program)(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Sobi
External Quality Operation Manager (EQOM)(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Novartis Pharma AG
Analytical Expert (Postgraduate Early Talent Program)(m/w/x)
Full-timeInternshipWith HomeofficeBasel - Novartis
Site Quality Head(m/w/x)
Full-timeWith HomeofficeSeniorBasel - BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel