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 CSLs 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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. 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.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

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 Experience:

Director