Associate Director, Process Development Lead, Tech Ops

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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.

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.

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.

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. #J-18808-Ljbffr