Neurimmune is a clinical-stage biopharmaceutical company building next-generation antibody therapeutics. To further strengthen our organization, we are looking for an experienced:

CMC Project Lead/Manager

Positions are on a full-time, permanent basis. Successful candidates will work at the company on site at the Bio-Technopark in Schlieren / Zurich.

Ideal candidates combine strong technical expertise in biologics manufacturing and analytical testing with excellent project management skills and an understanding of the regulatory ecosystem.

Role and Responsibilities:

Manage CMC activities for product candidates from preclinical development through clinical trials.
Manage and oversee external partners including CDMOs, CROs, and testing laboratories.
Executing activities on time, on budget and according to highest quality standards.
Provide technical and scientific insight to external partners, acting as a knowledgeable counterpart in providing solutions to technical and operational challenges.
Interact closely with internal Clinical Development, R&D and leadership to ensure cross-functional alignment with overall objectives.
Support preparation and maintenance of regulatory documentation, submissions, and interactions with agencies including FDA and EMA.

Requirements:

Life Sciences background, MSc or PhD in Biotechnology, Biochemistry, Cell Biology or related discipline.
Several years of relevant professional experience in CMC, preferably in production process development, manufacturing, analytical testing or characterization of biological medicinal products.
Strong understanding of GMP and of CMC regulatory paths to drug approval.
Excellent project management skills including experience in managing CMC projects with CDMOs and CRO service providers.
Ability to work strategically while engaging confidently in detailed technical solutions.
Excellent communication skills. Fluency in English.

Contact

Christine Frei
Human Resources
Neurimmune AG
Phone: +41 44 755 46 00