Associate Director, Process Development Lead, Tech Ops — CSL Behring
NewCHF 94'500 - 143'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- 3 days ago
SalaryCHF 94'500 - 143'000
Role overview
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.
- 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
Main responsibilities
- 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
Company and context
- 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
- 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
Notes and original content
- Ensure compliance with GMP, internal procedures, and regulatory expectations Qualifications & Experience
