Senior Scientist CMC (Early Development)

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