BiomeBank is seeking an experienced Chief Operating Officer to join our executive team as we enter an important stage of growth and development.
We are an Australian headquartered biotechnology company developing and commercialising microbiome based therapies. As the organisation grows, we are seeking a senior operational leader who can integrate the different functions of the business and ensure our strategic priorities are translated into well-planned, disciplined execution.
Reporting to the CEO, the COO will have broad responsibility across commercial operations, technical operations and manufacturing, quality, development and regulatory affairs, people and workplace, systems, data infrastructure and AI enablement.
The role The COO will be responsible for the effective integration and performance of BiomeBank’s operating functions, ensuring priorities are appropriately sequenced and resourced, risks and dependencies are identified early, and commitments are delivered.
A key focus will be strengthening the operating structures, systems and disciplines required as BiomeBank continues to develop and scale.
Working closely with the CEO and executive leadership team, the COO will lead a multidisciplinary senior team and provide the operational oversight required across development, manufacturing, quality, regulatory and commercial activities.
Key responsibilities include:
- Leading the senior team across commercial, technical operations, quality, development and regulatory affairs, and people and workplace
- Establishing and maintaining a disciplined operating rhythm, including organisational priorities, performance measures, planning cycles and structured reporting
- Overseeing manufacturing operations, facilities, engineering and capacity planning to support current and forecast requirements
- Leading the receiving side of technology transfer from R&D; into manufacture, including scale-up, process validation and continued process verification
- Working closely with R&D; and technical leaders to ensure manufacturing feasibility and constraints are considered throughout the development process
- Providing executive oversight of the Quality Management System and regulatory compliance in manufacturing, while maintaining the appropriate independence and authority of the quality function
- Ensuring development and regulatory programs are appropriately resourced and operating functions deliver against agreed development plans and milestones
- Working with the commercial function to ensure partnering and revenue commitments are aligned with technical feasibility, manufacturing capacity and operational capability
- Overseeing the systems, processes and management information required to support effective decision-making across the organisation
- Leading the operational implementation of BiomeBank’s AI and data infrastructure roadmap, including appropriate governance, data quality and the systems required to support future computational capability
- Providing executive oversight of information technology, cyber security and the protection of BiomeBank’s scientific, clinical and operational data
- Building organisational and leadership capability and ensuring the business has the people, structures and resources required to support its continued development
About you
You will be a senior operational expert with substantial experience in a regulated life sciences or advanced manufacturing environment, ideally within biotechnology, pharmaceuticals, biologics, cell or tissue therapies, advanced therapies or a comparable GMP setting.
You will have demonstrated experience leading complex operations through periods of growth and increasing organisational maturity, with a strong understanding of the operational requirements associated with product development, technology transfer, process scale-up, validation and regulated manufacture.
- Significant senior leadership experience across multidisciplinary scientific, technical, manufacturing and/or operational functions within a regulated environment
- Demonstrated experience in technology transfer and the scale-up of products or processes from development into GMP manufacture, including an understanding of process validation, manufacturing readiness and ongoing process performance
- Strong knowledge of GMP operations, quality systems and regulatory requirements, with an understanding of the importance of independent quality decision-making
- Experience establishing robust operating frameworks, including integrated planning, program governance, stage-gate decision-making, performance measures, risk management and structured reporting
- Strong commercial and operational judgement, with the ability to assess commercial opportunities and commitments against manufacturing capacity, technical feasibility, regulatory requirements, resourcing and organisational capability
- Highly developed decision-making capability, including the ability to evaluate complex technical and commercial information, identify material risks and dependencies, balance competing priorities and make explicit, timely decisions where information may still be developing
- Experience leading complex cross-functional programs where delivery depends on effective coordination between R&D;, development, regulatory, quality, manufacturing and commercial teams
- The ability to establish clear expectations and performance standards, address issues directly and ensure decisions and agreed actions translate into delivery
- Strong capability in capacity planning, resource allocation and operational prioritisation
- An informed understanding of data infrastructure, laboratory systems, automation, artificial intelligence and machine learning applications within life sciences, sufficient to provide effective executive oversight and evaluate proposed investments, systems and approaches
Experience with live biotherapeutic products, microbiome therapeutics, faecal microbiota transplantation, biologics or advanced therapies would be highly regarded. Exposure to TGA or international regulatory inspections, laboratory automation, LIMS, data infrastructure or computationally enabled development environments would also be advantageous.
An undergraduate qualification in science, engineering, biotechnology or a related discipline is preferred, or equivalent senior executive capability gained through substantial experience in regulated manufacturing. Postgraduate qualifications in business, management or governance would be advantageous.
This role does not require the COO to be the technical specialist in every discipline. It does require sufficient technical depth to engage credibly with scientific, manufacturing, quality and regulatory leaders; interrogate assumptions and evidence; understand the implications of technical decisions; and determine when an issue requires further investigation, escalation or a transparent executive decision.
You will be comfortable operating in an environment where scientific, regulatory, operational and commercial considerations frequently intersect, and where sound judgement, disciplined execution and well-reasoned decision-making are critical.
The opportunity
BiomeBank is at a stage of development where the continued progression of its therapeutic programs and commercial activities requires increasingly sophisticated operational capability.
The COO will work closely with the CEO and executive team to ensure the organisation has the operating structures, systems, resources and leadership capability required to support its development, regulatory, manufacturing and commercial priorities.
This is a senior executive position with broad organisational responsibility and significant involvement in the operational development of the business as it continues to scale.
If your experience aligns with the requirements of the role, we welcome your application via LinkedIn, or email
[email protected]
📌 Chief Operating Officer (Adelaide)
🏢 BiomeBank
📍 Adelaide