Scientist Cmc Analytical Development
il y a 1 semaine
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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