Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Full-time/Part-timeWith HomeofficeSenior
Schaftenau
from 65,605.54 / year
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NONovartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Schaftenau
from 65,605.54 / year
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
Leading analytical data package creation for drug-device combination products, coordinating outsourced analytical projects with CROs. Proven knowledge in late phase parenteral analytical development and leadership experience in global matrix projects required. On-site childcare facilities.
Requirements
- Master or PhD in engineering, chemical/bio analytics, or equivalent
- Some working experience in pharmaceutical industry in combination product development
- Proven knowledge in late phase parenteral analytical development
- Leadership experience in managing development projects in a global matrix environment
- Understanding and awareness of regulatory guidelines for combination product analytics
- Experience with cGMP and relevant ISOs
- Collaborative spirit
- Self-driven attitude
- High level of learning agility
- Proficiency in English (written and spoken)
Tasks
- Lead the creation of analytical data packages for drug-device combination products
- Coordinate project-specific analytical tasks for functional attributes at all levels
- Plan resources and budget for projects
- Select testing laboratories based on resource availability and capabilities
- Lead outsourced analytical project activities at CROs
- Manage external partnerships effectively
- Own and document drug-specific analytical methods and parameter sheets
- Organize and align cross-functional inputs with Device/Pack Tech
- Define and validate analytical methods and parameter sheets
- Co-author cross-functional analytical CMC strategies and documents
- Organize input for Justification of Specification from Device/Pack Tech and HFE
- Contribute to and review regulatory documents for product registrations
- Support product registrations and present at inspections with minimal support
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development opportunities
Career Advancement
- Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NONovartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Schaftenau
from 65,605.54 / year
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
Leading analytical data package creation for drug-device combination products, coordinating outsourced analytical projects with CROs. Proven knowledge in late phase parenteral analytical development and leadership experience in global matrix projects required. On-site childcare facilities.
Requirements
- Master or PhD in engineering, chemical/bio analytics, or equivalent
- Some working experience in pharmaceutical industry in combination product development
- Proven knowledge in late phase parenteral analytical development
- Leadership experience in managing development projects in a global matrix environment
- Understanding and awareness of regulatory guidelines for combination product analytics
- Experience with cGMP and relevant ISOs
- Collaborative spirit
- Self-driven attitude
- High level of learning agility
- Proficiency in English (written and spoken)
Tasks
- Lead the creation of analytical data packages for drug-device combination products
- Coordinate project-specific analytical tasks for functional attributes at all levels
- Plan resources and budget for projects
- Select testing laboratories based on resource availability and capabilities
- Lead outsourced analytical project activities at CROs
- Manage external partnerships effectively
- Own and document drug-specific analytical methods and parameter sheets
- Organize and align cross-functional inputs with Device/Pack Tech
- Define and validate analytical methods and parameter sheets
- Co-author cross-functional analytical CMC strategies and documents
- Organize input for Justification of Specification from Device/Pack Tech and HFE
- Contribute to and review regulatory documents for product registrations
- Support product registrations and present at inspections with minimal support
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development opportunities
Career Advancement
- Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Novartis Pharmaceutical Manufacturing GmbH
Industry
Pharmaceuticals
Description
The company aims to reimagine medicine to improve and extend people's lives.
Not a perfect match?
- Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis Pharmaceutical Manufacturing GmbH
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Full-timeWith HomeofficeSeniorKundlfrom 65,605.54 / year - Novartis
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Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year