Jobdescription

Location : Bulle, Switzerland

Activity rate : 100%

Type of contract : Temporary contract (until 31.12.2025 with possible extensions)

Start Date : ASAP

The External Manufacturing Operations Lead (EMOL) is responsible for overseeing the performance of CDMOs (Contract Development and Manufacturing Organizations) and critical suppliers within their portfolio. The role focuses on ensuring reliable supply, robust manufacturing processes, and rapid issue resolution, while fostering strong relationships with both external partners and internal stakeholders. Acting as the "Virtual Site Head," the EMOL coordinates necessary internal resources and sets priorities to meet downstream business needs. This role requires a deep understanding of technical, GMP, and regulatory aspects, along with the ability to drive continuous improvement initiatives and maintain compliance across the external manufacturing network.

Key Responsibilities :

• CDMO Performance Management :

Ensure the reliability of manufacturing plans, process robustness, and responsiveness to issues, while building strong relationships with CDMOs and internal teams.

Lead CMO Vendor Teams, coordinating inter-company activities, capability assessments, and resource needs.

Lead or participate in initiatives to foster a culture of operational excellence within External Manufacturing.

Conduct regular performance evaluations of CDMOs, identifying and implementing improvements in quality, cycle times, and costs.

Provide technical expertise to optimize processes and resolve complex production and supply issues, leading CAPA implementation when necessary.

Identify opportunities for performance improvements, develop long-term plans, and manage risks related to capacity and supply chain disruptions.

Ensure CDMOs comply with regulatory standards and industry best practices, maintaining inspection readiness.

Define operational and commercial strategies for CDMOs, managing risk and representing the client in supply review meetings.

Maintain and share expertise on outsourcing activities and market trends.

Manage and mentor junior EMOLs, supporting their professional growth.

Functie-eisen

What will make you successful :

Strong negotiation and influencing skills, with the ability to drive results and hold teams accountable.

Significant experience in Drug Substance (DS) manufacturing, particularly with antibodies, biologics, or large molecules.

Experience leading cross-functional teams and managing relationships across functions like Supply Chain, Quality Assurance, and Regulatory.

Capable of analyzing business cases and balancing long-term planning with immediate operational challenges.

Laetitia Stirer