GrL, Manufacturing Process Support

The Process Development Lead is a key leadership role within Technical Operations, responsible for leading global process development teams and driving the development, optimization, and implementation of robust and scalable manufacturing processes for plasma-derived biotherapeutics.

This role combines strong people leadership, technical expertise, and strategic execution to deliver early- to late-stage development programs, lifecycle management activities, and innovation initiatives aligned with CSL’s product portfolio and Quality by Design (QbD) principles.

Main Responsibilities & Accountabilities

• Accountable for the development and execution of short- to mid-term strategies for drug substance process development, including new product introduction and lifecycle management activities

• Provide technical and project leadership for process development activities from pre-clinical stage through product launch across the plasma-derived portfolio

• Lead process development for major manufacturing changes to unit operations, ensuring robust, scalable, and compliant processes

• Drive the assessment, selection, and implementation of innovative technologies to improve process performance, scalability, and product quality

• Promote and embed a Quality by Design (QbD) development approach, ensuring alignment with regulatory expectations and internal standards

• Act as a change agent to advance new ways of working, including adoption of advanced manufacturing and digital approaches

• Lead Process Development execution activities and ensure alignment with project governance and portfolio priorities

• Ensure preparation, review, and approval of high-quality technical documentation and regulatory submissions

• Collaborate closely with Process Engineering, Manufacturing, and other stakeholders to ensure effective scale-up, technology transfer, and facility fit assessments

• Oversee and ensure successful transfer of processes from development to commercial manufacturing

• Engage with external partners (CROs, vendors) to optimize capabilities, resources, and project outcomes

• Lead and Manages team of employees with respect to resource planning and staff allocation to projects involving the discovery, development and manufacture of new products as well as improvements to existing products.

• Drive talent development, succession planning, and capability building within the organization

• Foster a high-performance culture focused on scientific excellence, collaboration, and accountability

• Ensure execution of development activities in alignment with project timelines, quality standards, and regulatory requirements

• Drive continuous improvement of processes, tools, and ways of working within the function

• Ensure compliance with GMP, internal procedures, and regulatory expectations

Qualifications & Experience

• Required: Postgraduate degree (preferably PhD) in Life Sciences, Engineering, or related discipline

• Extensive experience in biotechnology, pharmaceutical industry, or relevant academic environment

• 10+ years of relevant experience in process development, manufacturing, or related fields

• Proven experience leading teams and managing complex, cross-functional programs

• Strong scientific background in drug substance process development, particularly for biologics or plasma-derived products

• Demonstrated ability to lead and develop high-performing teams in a global, matrixed environment

• Experience across early- to late-stage development, including scale-up, tech transfer, and regulatory submissions

• Strong analytical, problem-solving, and decision-making skills

• Excellent communication, stakeholder management, and influencing skills

• Experience working in multicultural, international environments

Was wir bieten

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Über CSL Behring

CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

CSL soll so vielfältig sein wie die Welt, in der wir leben

Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.

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