Scientist Cmc Analytical Development

il y a 1 semaine


Gent, Flandre, Belgique Argenx Temps plein

Key Accountabilities and Responsibilities:
Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by:

  • Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory requirements;
  • Drives tech transfer of analytical methods between sites;
  • Contributing to global analytical testing strategies with internal and external stakeholders;
  • Supporting cross‐site analytical oversight and harmonization;
  • Contribute to analytical comparability testing strategies and protein characterization;
  • Contribute to specification setting for development, pre‐commercial and commercial stage programs;
  • Contributing to strategic decision making on the basis of a deep understanding of protein behavior;
  • Contribute to statistical trending program to support specification setting and annual product quality reviews and analytical method controls across different testing sites;
  • Contributes to the write up of IMPD / IND / BLA quality dossier packages and drafting responses to health agency questions.

Qualifications:

  • Strong technical expertise in analytical method development, validation and protein characterization;
  • PhD or Master in Sciences;
  • Strategic and rationale thinker; able to make data‐based decisions;
  • Team player; able to build effective relationships with internal and external stakeholders;
  • Experience with writing/review of registration dossier sections is a plus (IND/IMPD/BLA/MAA);
  • Excellent writing skills;
  • Eye for detail and quality conscious attitude;
  • Well organized;
  • Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines and changing priorities, flexibility is a must;
  • Fluent in English our working language;

Offer:

  • A competitive salary package with extensive benefits
  • Front seat in the development of therapeutic antibodies
  • A work environment in a human‐sized, dynamic and rapidly growing biotech company


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