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Senior Manager Downstream Operations
2 months ago
Job Summary
CSL is seeking a highly experienced Senior Manager Downstream to lead the Downstream Manufacturing operations in our Biotechnology Manufacturing Facility (BMF). As a key member of the management team, you will collaborate with cross-functional groups to ensure efficient and safe drug substance manufacturing processes.
Key Responsibilities
- Manage production activities to ensure completion of operations following the project schedule and global project production schedule.
- Ensure all production deviations are reported and participate in the evaluation of all deviations; plan, lead, and execute activities relating to the investigation of critical deviations.
- Contribute to validation projects and risk assessments for processes, facility, and equipment, and develop risk management strategies.
- Participate in various BMF project activities and partner with other functional groups involved in technical transfer of manufacturing processes to the BMF.
- Recommend modifications to operational procedures to improve operational integrity, increase facility capacity and capability, reduce operating and GMP risks, and improve operating safety and success.
Requirements
- Tertiary qualifications in Biological Sciences, Biotechnology, or Chemical Process or Science Engineering.
- 5+ years of experience in relevant production and quality environments.
- Significant experience in a relevant pharmaceutical production environment.
- Demonstrated understanding of cGMP, regulatory requirements, and relevant environmental, health, and safety requirements in manufacturing areas.
- Demonstrated ability to coordinate project activities and liaise across functional groups to meet project targets and objectives.
About CSL
CSL is a global biotechnology leader with a commitment to improving the lives of patients worldwide. We are a dynamic and innovative organization with a strong focus on research and development, manufacturing, and commercialization of life-saving therapies.
