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CMC Stability Scientist

Job description

For a biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics, we are looking for a (Senior) Scientist CMC Stability. The Scientist CMC Stability will be a key member of the CMC analytics team being responsible for the design and follow‐up of stability programs of our therapeutic drug candidates throughout clinical development towards market approval and beyond. This position offers a unique opportunity to contribute to the development of novel therapeutics to treat patients with severe autoimmune diseases.

Reports 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 design of global stability programs for drug substance and drug product in accordance with the compound development plans and in alignment with applicable regulatory requirements;
  • Drives stability oversight and harmonization across the entire manufacturing network;
  • Drives the statistical trending program to support specification setting, annual product quality reviews; and expiry dating / shelf life determination;
  • Contributes to building understanding of protein behaviour;
  • Contributes to specification setting for development, pre‐commercial and commercial stage programs;
  • Drives implementation of specification changes throughout development and commercial;
  • Contributes to the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory requirements;
  • Contributes to the write up of IMPD / IND / BLA / MAA quality dossier packages and drafting responses to health agency questions.
Skills and personality
  • 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‚Äêsized, dynamic and rapidly growing biotech company
Contract

Executive search

Experience

minimum 5 years

Education

Bachelor and/or Master in Pharmaceutical and Biological techniques

Languages

English

Sector

Pharmaceutical industry

Region

Ghent

Job type

Full-time

 
 

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