Clinical Trial Supply Specialist
You will lead CMC activities in support of our clinical development programs.
CMC aspects of the product development, and management of external contributors, will be a priority. These include process development, analytical development, formulation development, manufacturing, analytical testing, fill and finish, packaging and labelling. CMC regulatory filings as well as support of regulatory activities authorities to IND and CTA filings will be important aspects of the work.
The following qualifications are required:
Experience in CMC and project management including budget, timelines and risk management
Experience in biologics drug development and managing external contributors including CMOs
In-depth knowledge of current GMP guidelines, familiarity with regulatory authority submissions (IMPD/IND/BLA), quality and technical agreement drafting
A BSc or MSc degree in Biochemistry, Biotechnology, Molecular Biology or equivalent
You should be well organized, work efficiently with a focus on deliverables, and enjoy working cross-functionally. A good knowledge of English is required.
If you are interested in this position, please forward your resume along with a letter of motivation to:
Christine Frei, Human Resources
Neurimmune AG, Wagistrasse 13, CH-8952 Schlieren