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.

You’ll also focus on establishing continuous improvement systems for PSO, monitoring technology trends, and strategy development, ensuring alignment with broader Bioprocess Product Development (BPD) strategies.

Your Responsibilities

Reporting to the Director, Pilot Scale Operations within Bioprocess Development you will be responsible for:

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

Your Experience

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

To apply, submit your CV no later than Monday 25th November.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.