Careers

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.

If you are interested in this position, please submit your application here.