Analytical Project Manager

CK Group
Pratteln
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Analytical Project Manager

Jocelyn Blackham is recruiting for an Analytical Project Manager to join an exciting biopharmaceutical company with an interesting pipeline.

The role is offered on a 12 month contract basis.

Analytical Project Manager role :

  • Responsible for the state- of the art development of analytical methods for new drug substances and drug products being selected for preclinical and clinical development.
  • Management of a product portfolio of approx. 2-4 projects (depending on the live cycle of the project).
  • Managing analytical projects with external partners. Main contact for external sites, e.g., CMOs and CROs, for defined analytical tasks.

Key duties will include :

  • Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification / validation-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
  • Representation of AD / QC in technical project team and Product team meetings.
  • Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience :

  • Open to candidates with a BSc and MSc with a wealth of industry experience, alternatively a PhD followed by some interesting industry experience.
  • Knowledge of the GMP / regulatory requirements, a strong background in analytical chemistry is required.
  • Proven track record of managing people in a matrix system.
  • Il y a plus de 30 jours
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