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Senior Manager Downstream
2 months ago
The Opportunity
Career opportunities have arisen in our Biotechnology Manufacturing Facility (BMF) for a Senior Manufacturing Manager – Downstream. Reporting to the Director – Biotechnology Manufacturing Facility and based at our Broadmeadows site, you will be a member of the management team and collaborate in the general management of the facility. You will lead the Downstream Manufacturing operations in manufacturing CSL's clinical human therapeutic products.
The BMF facility uses mammalian cells and DNA technology to manufacture drugs that will be used to treat life-threatening diseases. The facility works with Process Development, Quality, and other technical and business functions to ensure efficient and safe drug substance manufacturing processes to produce multiple recombinant proteins.
The Role
- Manage production activities to ensure completion of operations following the project schedule and the global project production schedule.
- Ensure that 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 the 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 the facility capacity and capability, reduce operating and GMP risks and improve operating safety and success.
Your Skills and Experience
- 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 co-ordinate project activities and liaise across functional groups to meet project targets and objectives
Apply now for a role with a varied remit in an organisation that is going through considerable investment and change.
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