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External Collaboration Expert - Analytical Development(m/w/x)
Developing cGMP-compliant testing processes and leading outsourcing strategy for Contract Lab Organizations in pharma. 10 years in pharmaceutical industry, 5 years in leadership, and substantial external partner experience required. Coordination with global cross-functional partners.
Requirements
- PhD or Master's degree in chemistry
- Bachelor’s degree with relevant experience
- At least 10 years in pharmaceutical industry
- Minimum 5 years in leadership position
- Substantial experience with external partners
- Experience in cGMP environment
- Solid understanding of analytical chemistry
- Experience with HPLC, GC, dissolution
- Excellent knowledge of cGMP regulations
- Proven experience with GMP inspections
- Strong negotiation skills
- Ability to build collaborative relationships
- Comfortable with frequent changes
- Ability to manage parallel activities
- Solid project management skills
- Systems-thinking approach
- Continuous improvement mindset
Tasks
- Lead the analytical outsourcing strategy for testing.
- Guide PTDC-A professionals in external testing.
- Coordinate with cross-functional partners on outsourcing.
- Develop cGMP-compliant testing processes and support audits.
- Define and monitor KPIs for Contract Lab Organizations.
- Identify new externalization opportunities and suitable CLOs.
- Promote continuous improvement and lean leadership principles.
- Contribute to strategic goal setting and onboarding.
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
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External Collaboration Expert - Analytical Development(m/w/x)
Developing cGMP-compliant testing processes and leading outsourcing strategy for Contract Lab Organizations in pharma. 10 years in pharmaceutical industry, 5 years in leadership, and substantial external partner experience required. Coordination with global cross-functional partners.
Requirements
- PhD or Master's degree in chemistry
- Bachelor’s degree with relevant experience
- At least 10 years in pharmaceutical industry
- Minimum 5 years in leadership position
- Substantial experience with external partners
- Experience in cGMP environment
- Solid understanding of analytical chemistry
- Experience with HPLC, GC, dissolution
- Excellent knowledge of cGMP regulations
- Proven experience with GMP inspections
- Strong negotiation skills
- Ability to build collaborative relationships
- Comfortable with frequent changes
- Ability to manage parallel activities
- Solid project management skills
- Systems-thinking approach
- Continuous improvement mindset
Tasks
- Lead the analytical outsourcing strategy for testing.
- Guide PTDC-A professionals in external testing.
- Coordinate with cross-functional partners on outsourcing.
- Develop cGMP-compliant testing processes and support audits.
- Define and monitor KPIs for Contract Lab Organizations.
- Identify new externalization opportunities and suitable CLOs.
- Promote continuous improvement and lean leadership principles.
- Contribute to strategic goal setting and onboarding.
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring everyone has access to healthcare. With over 100,000 employees globally, Roche aims to deliver life-changing healthcare solutions that make a global impact.
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