(Senior) Scientist Cmc Analytical Development

il y a 3 semaines


Gent, 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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