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Senior Scientist CMC Analytical Development
To further strengthen the CMC team, we are looking for a (Senior) Scientist CMC Analytical Development. The Scientist CMC Analytical Development will be responsible for the development and validation of analytical methods for testing and characterization of our therapeutic drug candidates throughout clinical development towards market approval. This is a unique opportunity to contribute to the development of novel therapeutics to treat patients with severe autoimmune diseases.
Report to: Analytical Development Lead
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.
- Contributes to the write up of IMPD / IND / BLA quality dossier packages and drafting responses to health agency questions.
- 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.
- 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