External Manufacturing Operations Lead
Date de publication :
30 novembre 2024Taux d'activité :
100%- Lieu de travail :Bulle
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.
- Leadership of Cross-functional Teams:
Lead CMO Vendor Teams, coordinating inter-company activities, capability assessments, and resource needs.
- Operational Excellence:
Lead or participate in initiatives to foster a culture of operational excellence within External Manufacturing.
- Performance Monitoring:
Conduct regular performance evaluations of CDMOs, identifying and implementing improvements in quality, cycle times, and costs.
- Technical Support & Issue Resolution:
Provide technical expertise to optimize processes and resolve complex production and supply issues, leading CAPA implementation when necessary.
- Continuous Improvement & Risk Management:
Identify opportunities for performance improvements, develop long-term plans, and manage risks related to capacity and supply chain disruptions.
- Compliance & Regulatory Management:
Ensure CDMOs comply with regulatory standards and industry best practices, maintaining inspection readiness.
- Strategic Planning & Vendor Relations:
Define operational and commercial strategies for CDMOs, managing risk and representing the client in supply review meetings.
- Technology & Market Knowledge:
Maintain and share expertise on outsourcing activities and market trends.
- Team Management:
Manage and mentor junior EMOLs, supporting their professional growth.
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qualifications
What will make you successful:
- Master's degree in a relevant field (e.g., Biotech, Life Sciences, Engineering, etc.).
- Skills & Competencies:
- Strong negotiation and influencing skills, with the ability to drive results and hold teams accountable.
- Effective crisis management and communication in high-pressure situations.Ability to think analytically and conceptually, with a focus on operational excellence.
- Fluent in English (written and spoken), with excellent interpersonal and team management skills.
- Experience & Expertise:
- Significant experience in Drug Substance (DS) manufacturing, particularly with antibodies, biologics, or large molecules.
- Proven ability to manage external partners (e.g., CMOs), resolve complex manufacturing issues, and present clear solutions to senior management.
- Experience leading cross-functional teams and managing relationships across Supply Chain, Quality Assurance, and Regulatory functions.
- Leadership & Stakeholder Management:
- Experience leading cross-functional teams and managing relationships across functions like Supply Chain, Quality Assurance, and Regulatory.
- Strong negotiation and influencing skills, with the ability to drive results and hold teams accountable.
- Business & Financial Acumen:
- Capable of analyzing business cases and balancing long-term planning with immediate operational challenges.
Laetitia Stirer
- Randstad UCB Bulle