CMC Project Lead/Manager
Company: Neurimmune
- Location: Schlieren, Switzerland
- Seniority: Director
- Employment type: Full-time
- Posted: 4 days ago
- Offer language: English
Job description
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.
