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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
Apply now

Creating data packages for drug-device combination products at a life sciences firm, coordinating outsourced activities at CROs. Master/PhD in engineering/analytics, pharma combination product development experience, and late-phase parenteral knowledge 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
  • 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
  • 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 for analytical projects
  • Own drug-specific analytical methods and parameter sheets
  • Organize and align cross-functional inputs for validation and transfer
  • 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
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