Associate Director, Process Development Lead, Tech Ops

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pThe 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. /ppThis 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. /ppbMain Responsibilities Accountabilities /b /plipAccountable for the development and execution of short- to mid-term strategies for drug substance process development, including new product introduction and lifecycle management activities /p /lilipProvide technical and project leadership for process development activities from pre-clinical stage through product launch across the plasma-derived portfolio /p /lilipLead process development for major manufacturing changes to unit operations, ensuring robust, scalable, and compliant processes /p /lilipDrive the assessment, selection, and implementation of innovative technologies to improve process performance, scalability, and product quality /p /lilipPromote and embed a Quality by Design (QbD) development approach, ensuring alignment with regulatory expectations and internal standards /p /lilipAct as a change agent to advance new ways of working, including adoption of advanced manufacturing and digital approaches /p /lilipLead Process Development execution activities and ensure alignment with project governance and portfolio priorities /p /lilipEnsure preparation, review, and approval of high-quality technical documentation and regulatory submissions /p /lilipCollaborate closely with Process Engineering, Manufacturing, and other stakeholders to ensure effective scale-up, technology transfer, and facility fit assessments /p /lilipOversee and ensure successful transfer of processes from development to commercial manufacturing /p /lilipEngage with external partners (CROs, vendors) to optimize capabilities, resources, and project outcomes /p /lilipLead 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. /p /lilipDrive talent development, succession planning, and capability building within the organization /p /lilipFoster a high-performance culture focused on scientific excellence, collaboration, and accountability /p /lilipEnsure execution of development activities in alignment with project timelines, quality standards, and regulatory requirements /p /lilipDrive continuous improvement of processes, tools, and ways of working within the function /p /lilipEnsure compliance with GMP, internal procedures, and regulatory expectations /p /lipbQualifications Experience /b /plipRequired: Postgraduate degree (preferably PhD) in Life Sciences, Engineering, or related discipline /p /lilipExtensive experience in biotechnology, pharmaceutical industry, or relevant academic environment /p /lilip10+ years of relevant experience in process development, manufacturing, or related fields /p /lilipProven experience leading teams and managing complex, cross-functional programs /p /lilipStrong scientific background in drug substance process development, particularly for biologics or plasma-derived products /p /lilipDemonstrated ability to lead and develop high-performing teams in a global, matrixed environment /p /lilipExperience across early- to late-stage development, including scale-up, tech transfer, and regulatory submissions /p /lilipStrong analytical, problem-solving, and decision-making skills /p /lilipExcellent communication, stakeholder management, and influencing skills /p /lilipExperience working in multicultural, international environments /p /lippbbAbout CSL Behring /b /b /p /ppCSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /ppbOur Benefits /b /p Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. /ppbr/CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.