R-245643 Senior Manager, Projects and Strategy

Your Role

The Senior Manager, Projects and Strategy is a pivotal role within CSL's bioprocess development network, operating at the interface of product development and CSL Melbourne's Pilot Scale Operations (PSO). The position involves managing a small team responsible for coordinating PSO development project activities, and developing a pilot scale operations strategy to efficiently meet future R&D pipeline needs.

This role ensures that project milestones are achieved on time, including scale-up, PSO development work packages, and technology transfer activities. You will establish best-in-class standards for project delivery and New Product Introduction, formulate strategic roadmaps for pilot scale operations, and drive strategy deployment.

• Provision of scientific leadership and project management for multiple concurrent projects being conducted within PSO
• Management of Senior Scientists direct reports and matrixed project staff
• Representing the department as pilot scale processing subject matter expert
• Identifying and driving improvement in project and development process (e.g. standardisation and simplification of processes, tech transfer into and out of PSO, scale-up, etc)
• Coordination of tech transfer documentation such as process design, risk assessments, process flow diagrams and bills of materials
• Establishing and embedding a Continuous Improvement system for Pilot Scale Operations including performance management systems and processes (e.g., tiered accountability, visual management, business performance review), 5S standards and improvement project frameworks
• PSO strategy development and deployment process, including defining key strategic initiatives required to achieve future goals, developing technology roadmaps to meet future manufacturing and BPD strategies
• Support the establishment and management of key PSO operational excellence systems and processes, such as coordinating PSO financial planning, annual budget preparation, reporting and control

• B./M./Sc/Eng./Ph.D. in Chemical/Biochemical Engineering, Chemistry/Biochemistry, or related discipline with relevant industry experience
• Industry experience in GMP manufacturing or product development related to the manufacture of therapeutic proteins for clinical investigation
• MBA, experience in strategy, or Tier 1 consulting experience is highly desirable
• Experience as an inspiring leader with strong and engaging employee management skills
• Proven ability to develop operational strategy by gathering and analysing information, formulating and testing hypotheses, and synthesising into a clear and communicable action plan
• Proven ability to influence and progress projects in the absence of direct reporting lines. Must be to handle many projects simultaneously and integrate project planning efforts across functions
• Good or working understanding and experience with GxP quality systems and Regulatory guidance's such as TGA, FDA, EMEA and ICH
• Understanding of cell culture, purification, formulation, and aseptic filling across PSO manufacturing activities