Associate Director, Process Development Lead, Tech Ops

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CSL is an Equal Opportunity Employer and welcomes applicants from all backgrounds.

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ph3Responsibilities /h3ulliAccountable for the development and execution of short- to mid-term strategies for drug substance process development, including new product introduction and lifecycle management activities. /liliProvide technical and project leadership for process development activities from pre-clinical stage through product launch across the plasma-derived portfolio. /liliLead process development for major manufacturing changes to unit operations, ensuring robust, scalable, and compliant processes. /liliDrive the assessment, selection, and implementation of innovative technologies to improve process performance, scalability, and product quality. /liliPromote and embed a Quality by Design (QbD) development approach, ensuring alignment with regulatory expectations and internal standards. /liliAct as a change agent to advance new ways of working, including adoption of advanced manufacturing and digital approaches. /liliLead process development execution activities and ensure alignment with project governance and portfolio priorities. /liliEnsure preparation, review, and approval of high-quality technical documentation and regulatory submissions. /liliCollaborate closely with Process Engineering, Manufacturing, and other stakeholders to ensure effective scale-up, technology transfer, and facility fit assessments. /liliOversee and ensure successful transfer of processes from development to commercial manufacturing. /liliEngage with external partners (CROs, vendors) to optimize capabilities, resources, and project outcomes. /liliLead and manage a 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. /liliDrive talent development, succession planning, and capability building within the organization. /liliFoster a high-performance culture focused on scientific excellence, collaboration, and accountability. /liliEnsure execution of development activities in alignment with project timelines, quality standards, and regulatory requirements. /liliDrive continuous improvement of processes, tools, and ways of working within the function. /liliEnsure compliance with GMP, internal procedures, and regulatory expectations. /li /ulh3Qualifications /h3ulliPostgraduate degree (preferably PhD) in Life Sciences, Engineering, or related discipline. /liliExtensive experience in biotechnology, pharmaceutical industry, or relevant academic environment. /lili10+ years of relevant experience in process development, manufacturing, or related fields. /liliProven experience leading teams and managing complex, cross-functional programs. /liliStrong scientific background in drug substance process development, particularly for biologics or plasma-derived products. /liliDemonstrated ability to lead and develop high‑performing teams in a global, matrixed environment. /liliExperience across early- to late-stage development, including scale-up, tech transfer, and regulatory submissions. /liliStrong analytical, problem‑solving, and decision‑making skills. /liliExcellent communication, stakeholder management, and influencing skills. /liliExperience working in multicultural, international environments. /li /ulh3Benefits /h3pFor more information on CSL benefits, visit the CSL benefits portal. /ppEqual Opportunity Employer.

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