External Manufacturing Operations Lead

vor 1 Monat


Fribourg, Schweiz Randstad (Schweiz) AG Vollzeit
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.
  • 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.
Functie-eisen

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

  • Fribourg, Schweiz Talentor Sweden AB Vollzeit

    **Responsibilites** - Interacts with biological Contract Manufacturers (CMOs, internal/external) in order to supply biological Drug Substances in the required quality, quantity, timing and cost; following defined production schedules, quality agreement and established manufacturing contracts. - Support and Manage technical projects (process and analytical...


  • Fribourg, Schweiz Bio-Rad Laboratories Vollzeit

    Ãberblick: Founded in 1952, Bio-Rad has developed into a recognized global leader in the growing life science research and clinical diagnostics markets. We’ve built a strong team of over 8,000 employees and a robust network of operations that serves over 150,000 customers worldwide. Bio-Rad employees share a common mission: To “Advance discovery and...


  • Fribourg, Schweiz Bio-Rad Laboratories Vollzeit

    Présentation: Founded in 1952, Bio-Rad has developed into a recognized global leader in the growing life science research and clinical diagnostics markets. We’ve built a strong team of over 8,000 employees and a robust network of operations that serves over 150,000 customers worldwide. Bio-Rad employees share a common mission: To “Advance discovery...

  • Director Manufacturing

    vor 7 Monaten


    Fribourg, Schweiz Bio-Rad Laboratories Vollzeit

    Présentation: For our site in Cressier (FR), we are looking for a **Director Manufacturing - Immunohematology** (M/F/d) - 100%. **How You'll Make an Impact**: - Manage manufacturing operations on one or several plants, including Switzerland: - Ensure yearly production plan on the different plants and avoid product shortage - Ensure quality of products,...

  • Site Operations Manager

    vor 7 Monaten


    Fribourg, Schweiz Parker Hannifin Corporation Vollzeit

    **Position Summary** To further strengthen our **“Production”** **team in Fribourg, we are currently looking for** **“Site Production Manager”.** **The Position** As **“Site Production Manager”**, you will be part of the Site Management Team, reporting directly to the Business Unit Manager. You will be accountable to achieve operational...


  • Fribourg, Schweiz Takeda Pharmaceutical Vollzeit

    **More about us**: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages...


  • Fribourg, Schweiz FMC Corporation Vollzeit

    **_This role can be based either in Hørsholm, Denmark or in Geneva, Switzerland._** **About FMC** FMC is an agricultural sciences company that advances farming through innovative and sustainable crop protection technologies. FMC invests significant resources in discovering new active ingredients, developing innovative formulations and biologicals in...


  • Fribourg, Schweiz Meggitt Vollzeit

    **Head of Manufacturing Engineering**: - Requisition ID: 106998- Business Unit: Engine Systems Fribourg (2200)- Location: Fribourg, FR, Switzerland, 1752Meggitt PLC is a global engineering group specialised in extreme environment components and smart sub-systems for aerospace, defence and energy markets. Some 9’000 people are employed across manufacturing...


  • Fribourg, Schweiz Puma Energy Vollzeit

    **Main Purpose:**:**The External Relations Associate is responsible to support the external relations manager and the broader Corporate Affairs & ESG function, supporting on media monitoring, stakeholder engagement, conference participation and overall external communications activities.**:**Knowledge Skills and Abilities, Key Responsibilities**: **KEY...


  • Fribourg, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: **An exciting and challenging opportunity has become available at **Takeda Neuchâtel Plant** for an experienced **Head of Manufacturing Line(Vonvendi) **to join our **Leadership Manufacturing Team**.**: **This is an exciting career opportunity for an enthusiastic individual, operational excellence minded and change agile manufacturing...


  • Fribourg, Schweiz UNITED PARCEL SERVICE Vollzeit

    Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself...


  • Fribourg, Schweiz TechBiz Global GmbH Vollzeit

    Lead the TFLN process transfer to our CMOS manufacturing partner, ensuring a seamless and efficient transition. This responsibility will involve prolonged stays abroad. - Lead a team of process engineers to develop new PIC manufacturing processes, pushing the boundaries of current technologies. - Collaborate with R&D teams in design and characterization,...

  • Operations Controller

    vor 2 Wochen


    Fribourg, Schweiz Angst+Pfister Vollzeit

    You are passionate about actively lead further development of supply chain, logistics and production controlling tasks and processes? Do you want to be part of an international fast-paced environment with many opportunities to grow? Then we are looking for YOU as: Operations Controller (all genders) **WHAT YOU DO** - You support and control defined business...

  • Head of Operations

    vor 7 Monaten


    Fribourg, Schweiz Electra Vollzeit

    **What do we do ?**: **Born in 2021 from the desire to make cities less polluted and less noisy**, Electra is helping to shift usage towards electric mobility by tackling the main obstacle of recharging. **Electra is constantly innovating to facilitate the recharging of electric vehicles with a network of fast recharging hubs (15 to 30 minutes maximum) and...


  • Fribourg, Schweiz Deutsche Bank Vollzeit

    The SOC performs operational security monitoring and incident management while also operating a number of local instances of group wide security solutions. The SOC performs operational security monitoring and incident management while also operating a number of local instances of group wide security solutions. The function reports directly to the group SOC...


  • Fribourg, Schweiz Takeda Pharmaceutical Vollzeit

    **À propos du poste**: Le poste de lead reporte au superviseur de production et est principalement responsable de coordonner et soutenir les activités d’un groupe de technciens dans la fabrication d’une substance pharmaceutique active selon des procedures strictes et rigoureuses (Bonnes pratiques de Fabrication). **Comment vous contribuerez**: Le...

  • Supply Chain

    vor 7 Monaten


    Fribourg, Schweiz Parker Meggitt Vollzeit

    The Supply Chain and R&D Controller applies analytical expertise in performing economic research on rates of return, depreciation and investments, and analysis of profit-and-loss income statements. Prepares reports and makes recommendations to management, while ensuring the integrity of accounting records for completeness, accuracy and compliance with...

  • Head HR Operations

    Vor 5 Tagen


    Fribourg, Schweiz Connect44 Vollzeit

    Head HR Operations Permanent Role Zurich - Switzerland On behalf of our client, a well known Swiss Company, we are currently looking for a German & English speaking Head HR Operations, for a role based at our client's site in Zurich - Switzerland **Head HR Operations** **Permanent Role** **Zurich - Switzerland** On behalf of our client, a well known...


  • Fribourg, Schweiz World Economic Forum LLC Vollzeit

    The World Economic Forum, committed to improving the state of the world, is the international organization for public-private cooperation. The Forum engages the foremost political, business, and other leaders of society to shape global, regional and industry agendas. Why we are recruiting We are seeking a Lead, Product Portfolio and Growth to drive the...


  • Fribourg, Schweiz Morgan Philips Executive Search Vollzeit

    We are recruiting on behalf of our client, a top international player in the restaurant industry for a Director of Operations. Accountable for leading and directing restaurant operations leadership of Switzerland. The role can be based either in Geneva or Zurich with 50% of traveling. Responsible for leading, coaching and directing Areas Managers and...