Associate Director, Process Development Lead, Tech Ops

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