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Novartis Pharmaceutical Manufacturing GmbH
last mo.

Senior Expert - Medical Device Analytical Representative(m/w/x)

Schaftenau
from 65,605.54 / year
Full-time, Part-timeWith Home OfficeSenior

Description

In this role, you will be at the forefront of developing analytical data packages for drug-device combination products, coordinating project tasks, and collaborating with cross-functional teams to ensure compliance and successful product registrations.

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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)

Education

Master's degree
OR
Doctoral / PhD

Work Experience

approx. 4 - 6 years

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

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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