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Analytical Project Leader(m/w/x)
Managing Technical CMC activities, defining control strategies for drug substances and products, with a focus on Oligonucleotides. PhD in chemistry, 5+ years pharma development leadership, and Oligonucleotides analytic experience required. Work in a global matrix environment, contributing to patient care improvement.
Requirements
- PhD in analytical chemistry or equivalent
- Minimum of 5 years’ experience in pharmaceutical industry in analytical development as project leader
- Experience in Oligonucleotides analytic
- Proven knowledge in Early or late phase parenteral development and filing
- Proven leadership experience in managing development projects in a global matrix environment
- Excellent understanding of regulatory guidelines for analytical development
- High level of intrinsic motivation to work with new development compounds
- Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences
- Ability to perform in a highly dynamic environment
- Excellent communication and role model skills
- Good understanding of using novel digital tools in global project management
- Fluency in English (oral and writing), German is a plus
Tasks
- Lead the analytical subteam
- Manage analytical activities within the Technical CMC project team
- Define control and specification setting strategies for drug substances and products
- Prepare analytical project plans
- Ensure quality, timelines, and budget compliance for assigned projects
- Forecast FTE and cost demand for projects
- Issue analytical source documents in a timely manner
- Provide scientific inputs for analytical CMC documents
- Support regulatory submissions
- Collaborate with internal and external stakeholders in drug development
- Coach analytical experts
- Lead outsourced analytical activities at CROs and CDMOs
- Manage external partnerships
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
- German – Basic
Not a perfect match?
- LonzaFull-timeOn-siteSeniorBasel
- Lonza
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Senior Expert Science & Technology (Analytical Chemistry Oligonucleotides)(m/w/x)
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Analytical Project Leader(m/w/x)
Managing Technical CMC activities, defining control strategies for drug substances and products, with a focus on Oligonucleotides. PhD in chemistry, 5+ years pharma development leadership, and Oligonucleotides analytic experience required. Work in a global matrix environment, contributing to patient care improvement.
Requirements
- PhD in analytical chemistry or equivalent
- Minimum of 5 years’ experience in pharmaceutical industry in analytical development as project leader
- Experience in Oligonucleotides analytic
- Proven knowledge in Early or late phase parenteral development and filing
- Proven leadership experience in managing development projects in a global matrix environment
- Excellent understanding of regulatory guidelines for analytical development
- High level of intrinsic motivation to work with new development compounds
- Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences
- Ability to perform in a highly dynamic environment
- Excellent communication and role model skills
- Good understanding of using novel digital tools in global project management
- Fluency in English (oral and writing), German is a plus
Tasks
- Lead the analytical subteam
- Manage analytical activities within the Technical CMC project team
- Define control and specification setting strategies for drug substances and products
- Prepare analytical project plans
- Ensure quality, timelines, and budget compliance for assigned projects
- Forecast FTE and cost demand for projects
- Issue analytical source documents in a timely manner
- Provide scientific inputs for analytical CMC documents
- Support regulatory submissions
- Collaborate with internal and external stakeholders in drug development
- Coach analytical experts
- Lead outsourced analytical activities at CROs and CDMOs
- Manage external partnerships
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
- German – Basic
About the Company
Novartis Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Not a perfect match?
- Lonza
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Group Head in Analytical Development & Quality Control(m/w/x)
Full-timeOn-siteManagementBasel - Novartis Pharma AG
Senior Expert Science & Technology (Analytical Chemistry Oligonucleotides)(m/w/x)
Full-timeOn-siteSeniorBasel