About the Role
We are seeking an experienced Process Science Leader to join our team. In this pivotal role, you will set the direction for Process Engineering within the Value Stream and align with global stakeholders to drive continuous improvement and technical excellence.
You will apply your scientific and engineering expertise to inform the design, implementation, and lifecycle management of complex products, processes, and technologies.
Key Responsibilities
* Champion a safety-first culture and ensure all activities are conducted in a safe and controlled manner.
* Support the launch of a filling line and product transfers to vial filling lines, resolving product and process issues.
* Develop and maintain the Automated Visual Inspection (AVI) seasonal variation change process.
* Build and embed MS&T Ways of Working within the area.
* Design and evolve tools to monitor Value Stream performance, informing priorities and resource allocation.
* Engage global partners and external support to address complex deviations, process improvements, and CAPA implementation.
* Lead technical investigations and Root Cause Analysis for process-related issues.
* Function as a key stakeholder for Global Platform Roadmaps, providing technical evaluation and risk mitigation strategies.
* Drive local and global process understanding and capability development for MS&T Principals and Senior Scientists.
* Set the direction for global Quality by Design (QbD) packages in collaboration with Process Engineering partners.
* Lead cross-functional Gemba walks to identify and implement improvement opportunities across streams and networks.
Qualifications & Experience
Bachelor's degree in engineering or science (Master's/PhD in Life Sciences is advantageous).
Minimum 7 years' experience in Process Science/Engineering within pharmaceutical, biotechnology, or chemical manufacturing industries.
Strong background in GMP manufacturing and highly regulated environments.
Proven ability to lead cross-functional initiatives, manage competing priorities, and deliver outcomes.
Experience with filling and AVI equipment process improvements and validated system changes.
Excellent stakeholder management, leadership, and communication skills.
Benefits
At CSL, you will be part of a global team committed to delivering life-saving therapies and driving innovation.
This role offers the opportunity to influence global processes, lead technical initiatives, and contribute to continuous improvement in a dynamic and collaborative environment.
About Us
CSL Behring is a global biotherapeutics leader driven by its 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.
Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL visit their website.