Join argenx as a Senior Scientist CMC (Early Development) to support cell line development, drug substance manufacturing process development, and analytical method development for clinical manufacture of therapeutic antibodies and Fc engineered molecules.
Requirements
- Masters / PhD in chemistry, pharmaceutical sciences, bio-engineering, or other discipline within pharmaceutical / biotechnology sciences
- Strong technical expertise in biological development and drug substance manufacturing, product and process characterization
- Strong knowledge of analytical methods (chromatography, bioassays, etc)
- Good understanding of USP and DSP strategies
- Expected experience: >3y within relevant industry
- Experience with tech transfer activities is a plus
- Desire to work in a fast-paced environment, and relevant experience in managing outsourced projects with external vendor
- Excellent organizational and coordination skills
- Ability to provide attention to detail whilst keeping the view on the overall project goal
- Strong technical expertise combined with good interpersonal skills and ability to communicate effectively with internal and external stakeholders
- Flexible attitude, capable to balance multiple priorities
- Quality conscious attitude
- Knowledge of the preparation of regulatory submissions
- Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines
- Fluent in English, written and spoken
- Good knowledge of ICH and GMP regulations
- Works independently within the scope of his assigned field and supports others
- Keep abreast with relevant scientific and/or technical developments
Benefits
- Competitive salary package
- Extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company