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Novartis Pharma AG
last mo.

Analytical Project Leader(m/w/x)

Basel
Full-timeOn-siteSenior

Description

As an Analytical Project Leader, you will guide a global team in the technical development of drug substances and products, ensuring project quality and timelines while collaborating with various stakeholders and managing external partnerships.

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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

Education

Doctoral / PhD

Work Experience

5 years

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

Languages

English – Business Fluent

German – Basic

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