Proclinical is seeking an Operational Excellence Manager to join our client, a pioneering biologics manufacturer establishing one of Australia's first commercial facilities dedicated to viral vector production for advanced therapies. Uniquely embedded within a major health, education, research, and innovation precinct, our client is positioning itself as a leading CDMO in the Asia–Pacific region.
As the organisation transitions from scale-up into full commercial operations, this newly created role will be central to operational scalability, process optimisation, and end-to-end customer delivery readiness. You'll build and embed a culture of continuous improvement, drive transformational initiatives, and shape the operational backbone of a world-class advanced therapies CDMO.
Why this role?
This is a rare opportunity to design and lead the operational excellence and PMO agenda for a first-of-its-kind advanced therapies facility in Australia – building the systems, rhythms, and ways of working that will underpin long-term commercial success.
Role Overview
Reporting to the Chief Operating Officer, the Operational Excellence Manager will develop and lead the site's operational excellence framework, mature performance systems, and integrate cross-functional workflows across Commercial, Process Development, Manufacturing, QC, QA and Supply Chain.
You'll lead the PMO function, elevate operational metrics and daily management rhythms, and drive digital enablement initiatives to strengthen throughput and right-first-time performance, ensuring operations remain aligned with relevant cGMP, TGA, PIC/S and international regulatory standards. You'll work closely with functional leads and project managers, with the ability to shape how the Operational Excellence and PMO capability grows over time.
Key Responsibilities
Continuous Improvement & Lean Leadership
* Design and lead the site's Operational Excellence framework (Lean, Six Sigma, 5S, Kaizen, visual management).
* Run value stream mapping and continuous improvement initiatives to remove waste and optimise flow.
* Coach teams in Lean tools and structured problem-solving to embed a culture of continuous improvement.
Process & Operational Performance
* Implement standardised processes, SOPs and visual management to improve flow and reduce variability.
* Mature daily performance management (KPIs, stand-ups, escalation) to drive accountability and delivery.
* Identify bottlenecks and implement countermeasures to improve cycle time and throughput.
Data, Metrics & Decision Support
* Own the operational KPI framework, dashboards and reporting cadence.
* Use data, trend analysis and SPC to proactively manage process performance and support key decisions.
Cross-Functional Integration & Customer Delivery
* Integrate processes across Commercial, Process Development, Manufacturing, Supply Chain and Quality.
* Optimise workflows for client onboarding, tech transfer, scheduling and release activities.
* Lead post-project reviews and embed improvements that strengthen customer experience and right-first-time delivery.
Systems & Digital Enablement
* Lead optimisation of key business systems (ERP, QMS, LIMS, CRM, project/work management).
* Map and digitise workflows in line with GMP and business rules to enable real-time operational visibility.
PMO Leadership
* Lead the Project Management Office (PMO) strategy, governance and project lifecycle approach.
* Develop PMO tools and coach Project Managers/Leads across customer and internal projects.
Skills & Experience
* Bachelor's degree in Engineering, Science or related discipline (or equivalent demonstrated experience).
* Significant experience in Operational Excellence / Continuous Improvement / Process Improvement within a regulated manufacturing environment (biotech, pharma, med devices, food manufacturing).
* Strong expertise in Lean, Six Sigma, and structured problem-solving with a track record of measurable outcomes (cost, quality, throughput, compliance).
* High analytical capability and experience with data visualisation/reporting tools.
* Excellent facilitation skills and confidence leading cross-functional teams and influencing at all levels.
* Customer-centric mindset with strong stakeholder management and communication skills.
Desirable:
* Start-up / scale-up experience
* Six Sigma Black Belt
* Familiarity with ERP platforms (NetSuite, SAP, Microsoft Dynamics, Syspro etc.)
* PM certification (PMI/PRINCE2/Agile), Asana exposure
How to Apply
If this opportunity aligns with your experience and career goals, please click 'Apply Now' to submit your application.
For a confidential discussion or to learn more, contact Pam Phoumavong at or call
About Proclinical
Proclinical is a specialist life sciences recruitment agency, providing job opportunities within leading pharmaceutical, biotechnology, biopharmaceutical, and medical device organisations worldwide. Proclinical Staffing is an equal opportunity employer.