CMC Project Lead/Manager

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.

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