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 optimise capabilities, resources and project outcomes
Lead and manage 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 organisation
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 programmes
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
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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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 optimise capabilities, resources and project outcomes
Lead and manage 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 organisation
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 programmes
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
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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Associate Director, Process Development Lead, Tech Ops Arbeitgeber: CSL
CSL ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern ein dynamisches und unterstützendes Arbeitsumfeld bietet. Mit einem starken Fokus auf persönliche Entwicklung und Weiterbildungsmöglichkeiten, insbesondere im Bereich Veranstaltungen und Transparenzmanagement, fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Lage ermöglicht es den Mitarbeitern, in einem inspirierenden Umfeld zu arbeiten, während sie gleichzeitig von attraktiven Benefits und einer ausgewogenen Work-Life-Balance profitieren.
