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Ensuring GMP-compliant methods and data for release and stability testing at a biopharmaceutical company. Strong GMP understanding and quality-minded analytical professional required. Work/life balance, health support.
Requirements
- Quality-minded analytical professional
- Enjoyment of cross-functional work
- Taking ownership
- Bringing structure to complex scientific work
- Strong GMP understanding
- Collaborative mindset
- Motivation to deliver high-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
- Deviation investigations
- Change control
- Ideally QA supporting QC or QC Coordinator
- 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
- Ensure GMP-compliant methods and data for release and stability testing
- Coordinate and approve deviations, CAPA, and change controls
- Approve GMP-related analytical activities, including validation and technology transfer
- Evaluate and ensure quality of CLOs
- Serve as QA contact for CLOs
- Approve stability study 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 and provide QA analytical guidance
- 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
Other Benefits
- Competitive benefits package
Healthcare & Fitness
- Health support
Mental Health Support
- Happiness support
Not a perfect match?
- Novartis Pharma AGFull-timeWith HomeofficeSeniorBasel
- BeOne Medicines I GmbH
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Ensuring GMP-compliant methods and data for release and stability testing at a biopharmaceutical company. Strong GMP understanding and quality-minded analytical professional required. Work/life balance, health support.
Requirements
- Quality-minded analytical professional
- Enjoyment of cross-functional work
- Taking ownership
- Bringing structure to complex scientific work
- Strong GMP understanding
- Collaborative mindset
- Motivation to deliver high-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
- Deviation investigations
- Change control
- Ideally QA supporting QC or QC Coordinator
- 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
- Ensure GMP-compliant methods and data for release and stability testing
- Coordinate and approve deviations, CAPA, and change controls
- Approve GMP-related analytical activities, including validation and technology transfer
- Evaluate and ensure quality of CLOs
- Serve as QA contact for CLOs
- Approve stability study 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 and provide QA analytical guidance
- 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
Other Benefits
- Competitive benefits package
Healthcare & Fitness
- Health support
Mental Health Support
- Happiness support
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 - BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel - Novartis
Site Quality Head(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Novartis Pharma AG
Analytical Expert (Postgraduate Early Talent Program)(m/w/x)
Full-timeInternshipWith HomeofficeBasel - Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel