Senior Manager, Early Upstream Development - Melbourne
We're hiring a Senior Manager, Upstream Process Development (USP) to join our team. You will lead a dedicated team for early USP Development at CSL, focusing on recombinant product development. You will manage a group of scientists and engineers to develop, optimize, and scale-up upstream processes, using the Sartorius Ambr platform.
You will help advance CSL's pipeline of recombinant products, ensuring the development of robust and scalable processes that meet regulatory requirements and industry standards.
You will be a leader with strong technical and communication skills, coupled with an aptitude to work on scientific challenges which influence drug development.
Reporting to the Director, Upstream Development in CSL Melbourne, with dual-line reporting to the Director of Cell-Line Development in Bio2, you will:
- Provide strategic guidance for early USP development approaches, aligned with the business strategy.
- Develop, mentor, retain, motivate, and inspire individuals in the team.
- Contribute to the Cell Line Development activities for the progression of Research projects by leading the planning, execution and analysis of bioreactor campaigns using Ambr mini-bioreactor systems. Lead delivery of early-phase process development work packages such as platform fit assessment and supporting late-stage development.
- Oversee the development, optimization, and scale-up of upstream processes for recombinant protein production using the Sartorius Ambr platform.
- Collaborate with cross-functional teams, including cell line development, downstream process development, analytical development, and quality assurance, to ensure seamless integration of upstream processes into the product development strategy.
- Prepare and review documentation for regulatory submissions and support regulatory inspections and audits.
Qualifications/Experience:
- Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, or a related field. A Master's degree with extensive relevant experience may be considered.
- Minimum of 6 years of experience in upstream process development, with at least 3 years in a leadership or managerial role.
- Demonstrated experience with the Sartorius Ambr platform and other advanced bioreactor systems.
- Demonstrated leadership experience including experience influencing senior management/critical stakeholders.
- Excellent project management and organisational abilities.
- In-depth knowledge of cell culture techniques, bioreactor operations, and process scale-up.
- Experience developing and optimising upstream processes for recombinant protein production.
- Familiarity with regulatory requirements and documentation for biopharmaceutical process development.
- Skills in data analysis, interpretation, statistical methods
Applications Close on 14 November 2024
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- Career, performance and development programs that enable success in your current position and foster your development and growth.
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