CMC Project Leader, Biologics & Regulatory

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 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.