In the respiratory field, developing a recombinant protein. CMC of the combination of protein and inhaler is carried out via contract manufacturers (CMOs/CDMOs). The molecule is about to enter first-in-human clinical trials. Currently operating with a small team, the company is offering a hands-on opportunity to actively manage CMC accompanying preclinical and the first clinical phase.
Responsibilities
- Operational CMC – Development of the combination product consisting of drug product and medical device
- Management and coordination of CMC activities along early development and manufacturing processes in collaboration with international CMOs/CDMOs
- Preparation and monitoring of timelines for the manufacture of clinical trial material and for the transfer of relevant manufacturing and analytical methods
- Strategic advice to management on CMC topics: which steps, when, and by whom? Translation of scientific requirements into operational workflows
- Preparation and maintenance of regulatory CMC documentation in accordance with ICH and EMA/FDA requirements (e.g. IMPD Module 3, dossier parts)
Requirements
- To collaborate at eye level with your colleagues, you have successfully completed a scientific degree (Master/Diploma/PhD) in molecular biology, biotechnology, chemistry, pharmacy or a related discipline
- Strong ability to move from strategic planning to operational execution: a hands-on mindset and a high level of personal responsibility are essential
- Several years of experience (> 2 years) in non-academic GMP process development for medical devices, ideally in combination with recombinant proteins, as well as in maintaining regulatory CMC documentation
- Ideally, experience in working with external service providers (CDMO management, contract negotiation, quality assurance)
