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Section Lead & Center of Excellence (CoE) Strategy Realization(m/w/x)
Leading a team of four associate scientists in formulation and process development for complex SM parenterals. Direct experience with regulatory CMC source and submission documents required. Strategic role within a global healthcare company's Center of Excellence.
Requirements
- Deep scientific expertise in formulation and process development for parenteral dosage forms
- Proven ability to lead and inspire a scientific team
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Problem-solving mindset and ability to manage multiple parallel projects
- Deep expertise in analytical methods for characterizing liquid formulations
Tasks
- Provide focus on formulation and process development strategies
- Deliver the complex SM parenterals portfolio
- Act as the Pharmaceutical Development SPOC for research organizations
- Conduct CMC risk assessments and develop mitigations for portfolio molecules
- Lead a team of four associate scientists
- Foster a collaborative and high-performing team environment
- Manage lab equipment capabilities for SM DP parenterals
- Ensure End-to-End connectivity with cross-functional partners
- Lead the team's operational focus and strategic direction
- Ensure adherence to stringent quality standards in laboratory work
- Maintain data integrity for non-GMP data in collaboration with partner functions
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Not a perfect match?
- RocheFull-timeOn-siteManagementBasel
- F. Hoffmann-La Roche AG
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Section Lead & Center of Excellence (CoE) Strategy Realization(m/w/x)
Leading a team of four associate scientists in formulation and process development for complex SM parenterals. Direct experience with regulatory CMC source and submission documents required. Strategic role within a global healthcare company's Center of Excellence.
Requirements
- Deep scientific expertise in formulation and process development for parenteral dosage forms
- Proven ability to lead and inspire a scientific team
- Direct experience in writing and reviewing regulatory CMC source and submission documents
- Problem-solving mindset and ability to manage multiple parallel projects
- Deep expertise in analytical methods for characterizing liquid formulations
Tasks
- Provide focus on formulation and process development strategies
- Deliver the complex SM parenterals portfolio
- Act as the Pharmaceutical Development SPOC for research organizations
- Conduct CMC risk assessments and develop mitigations for portfolio molecules
- Lead a team of four associate scientists
- Foster a collaborative and high-performing team environment
- Manage lab equipment capabilities for SM DP parenterals
- Ensure End-to-End connectivity with cross-functional partners
- Lead the team's operational focus and strategic direction
- Ensure adherence to stringent quality standards in laboratory work
- Maintain data integrity for non-GMP data in collaboration with partner functions
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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