CMC Project Lead/Manager

Neurimmune AG; Schlieren; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Neurimmune AG, based in Schlieren near Zurich, seeks an experienced professional to lead CMC activities for biologics candidates from preclinical through clinical development. The role requires coordinating with CDMOs, CROs, and testing laboratories, ensuring timely, budget-conscious, and high-quality execution.

The successful candidate will have a Life Sciences MSc or PhD, extensive GMP know-how, and strong English communication skills to interact with FDA/EMA and internal teams.

Qualifikationen

• Life Sciences degree required (MSc/PhD).
• Several years of experience in CMC, preferably in production process development, manufacturing or analytical testing of biologics.
• Strong GMP understanding and CMC regulatory paths to drug approval.
• Excellent project management, especially with CDMOs/CROs.
• Strategic thinker with ability to address detailed technical solutions.

Aufgaben

• Manage CMC activities for product candidates from preclinical to clinical stages.
• Oversee external partners including CDMOs, CROs and testing labs.
• Execute activities on time, within budget and to high quality standards.
• Provide technical insight to partners and resolve technical/operational challenges.
• Collaborate with Clinical Development, R&D and leadership for cross-functional alignment.
• Support regulatory documentation, submissions, and interactions with FDA/EMA.

Kenntnisse

CMC project management

Biologics manufacturing

External partner mgmt

Regulatory knowledge

English fluency

Ausbildung

MSc or PhD in Life Sciences

Jobbeschreibung

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

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.

Responsibilities include:

• 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.