Chief Operations Strategist for Bioprocess Development

5 hours ago

Parkville, Victoria, Australia 3065 CSL Innovation Full time

Job Overview

The Chief Operations Strategist for Bioprocess Development plays a pivotal role in driving the success of CSL's bioprocess development network. Reporting to the Director, Pilot Scale Operations within Bioprocess Development, this key position involves overseeing a small team responsible for coordinating project activities and developing a pilot scale operations strategy to efficiently meet future R&D pipeline needs.

This role ensures timely achievement of project milestones, including scale-up, PSO development work packages, and technology transfer activities. The successful candidate will establish best-in-class standards for project delivery and New Product Introduction, formulate strategic roadmaps for pilot scale operations, and drive strategy deployment.

Key Responsibilities

  • Scientific Leadership
  • Provide scientific leadership and project management for multiple concurrent projects being conducted within PSO.
  • Team Management
  • Manage Senior Scientists direct reports and matrixed project staff.
  • Subject Matter Expertise
  • Represent the department as pilot scale processing subject matter expert.
  • Process Improvement
  • Identify and drive improvement in project and development process (e.g., standardisation and simplification of processes, tech transfer into and out of PSO, scale-up, etc).
  • Tech Transfer Coordination
  • Coordinate tech transfer documentation such as process design, risk assessments, process flow diagrams, and bills of materials.
  • Continuous Improvement
  • Establish and embed 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
  • Develop and deploy a PSO strategy, including defining key strategic initiatives required to achieve future goals, developing technology roadmaps to meet future manufacturing and BPD strategies.
  • Operational Excellence
  • 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.

Requirements

  • Education and Experience
  • Bachelor's degree 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.
  • Leadership and Communication 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.
  • Quality Systems and Regulatory Knowledge
  • Good understanding and experience with GxP quality systems and regulatory guidance (e.g., TGA, FDA, EMEA, ICH).
  • Cross-functional Collaboration
  • Understanding of cell culture, purification, formulation, and aseptic filling across PSO manufacturing activities.

About the Role

The estimated salary for this position is AU$140,000 - AU$180,000 per annum, depending on experience. We encourage you to apply if you have the skills and qualifications we are looking for.

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