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CMC Expert Analytical Development focus Parenterals&Devices(m/w/x)
Analytical development guidance for parenteral and device products, mentoring NDA authoring in disease prevention. Extensive pharmaceutical research experience and NDA preparation track record required. Direct impact on life-changing solutions for global healthcare.
Requirements
- Advanced degree in a relevant scientific discipline
- Extensive experience in pharmaceutical research
- Proven track record in NDA preparation
- Strategic problem-solver with strong analytical skills
- Highly effective communicator with excellent interpersonal skills
- Thrives in a collaborative team environment
- Stays abreast of latest scientific advancements
- Natural mentor, passionate about training others
Tasks
- Provide scientific guidance to project teams.
- Mentor on NDA authoring and due diligence.
- Resolve complex CMC issues with root cause analyses.
- Shape scientific strategies using pharmaceutical experience.
- Collaborate with cross-functional teams on challenges.
- Analyze risks and design portfolio-wide solutions.
- Implement strategic projects to enhance operations.
- Train and mentor scientific staff for knowledge sharing.
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
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CMC Expert Analytical Development focus Parenterals&Devices(m/w/x)
Analytical development guidance for parenteral and device products, mentoring NDA authoring in disease prevention. Extensive pharmaceutical research experience and NDA preparation track record required. Direct impact on life-changing solutions for global healthcare.
Requirements
- Advanced degree in a relevant scientific discipline
- Extensive experience in pharmaceutical research
- Proven track record in NDA preparation
- Strategic problem-solver with strong analytical skills
- Highly effective communicator with excellent interpersonal skills
- Thrives in a collaborative team environment
- Stays abreast of latest scientific advancements
- Natural mentor, passionate about training others
Tasks
- Provide scientific guidance to project teams.
- Mentor on NDA authoring and due diligence.
- Resolve complex CMC issues with root cause analyses.
- Shape scientific strategies using pharmaceutical experience.
- Collaborate with cross-functional teams on challenges.
- Analyze risks and design portfolio-wide solutions.
- Implement strategic projects to enhance operations.
- Train and mentor scientific staff for knowledge sharing.
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
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