Chief Operating Officer

Key Responsibilities

1. Corporate Strategy and Business Operations

• Translate the company's corporate strategy and business objectives into actionable operational plans, milestones and performance targets.
• Work closely with the CEO and Board of Directors on strategic initiatives, business planning, corporate development and organisational growth.
• Support fundraising activities, investor presentations, strategic partnerships and due diligence processes.
• Lead the development and implementation of the company's annual operating plan, budget and resource allocation.
• Oversee day-to-day business operations to ensure organisational efficiency, accountability and alignment with strategic priorities.
• Establish appropriate organisational structures, operating procedures, governance frameworks and management reporting systems.
• Identify operational risks, bottlenecks and opportunities for process improvement.

2. Research and Development Operations

• Oversee the operational management of R&D programmes
• Ensure effective coordination between scientific research, process development, analytical development and research team.
• Establish project management frameworks to monitor R&D milestones, timelines, budgets and deliverables.
• Support the development of intellectual property, technology platforms and product pipeline in collaboration with the scientific leadership team.
• Ensure that R&D activities are aligned with the company's product development strategy and regulatory requirements.

3. Manufacturing and Process Development

• Lead the development and implementation of manufacturing strategies
• Oversee process development, scale-up, technology transfer and manufacturing readiness.
• Drive the establishment of robust and reproducible manufacturing processes, including upstream and downstream production.
• Ensure appropriate controls over raw materials, starting materials, production processes and critical quality attributes.
• Evaluate opportunities for contract development and manufacturing organisation (CDMO) partnerships and strategic outsourcing.

4. Quality Management and Regulatory Compliance

• Establish and maintain an effective Quality Management System (QMS) appropriate to the company's stage of development and intended product applications.
• Ensure compliance with applicable regulatory requirements, including relevant Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and other applicable quality standards.
• Oversee quality assurance, quality control, documentation, deviation management, corrective and preventive action, change control and risk management.
• Work closely with regulatory consultants and relevant authorities to develop regulatory strategies.
• Support the preparation of regulatory submissions, product dossiers, manufacturing documentation and clinical trial applications.
• Ensure appropriate product characterisation, identity, purity, potency, safety and consistency strategies are established.
• Maintain a culture of quality, regulatory compliance and continuous improvement throughout the organisation.

5. Clinical Development and Product Commercialisation

• Work with scientific, clinical and regulatory teams to develop product development and clinical translation strategies.
• Oversee operational planning and coordination for preclinical studies, clinical development programmes and external research collaborations.
• Support the development of product pipelines, target indications and commercialisation roadmaps.
• Identify opportunities for strategic collaborations with hospitals, universities, research institutions, clinical investigators and biotechnology partners.
• Develop operational capabilities to support future product registration, market entry and commercial manufacturing.
• Ensure that product development and commercialisation activities are aligned with applicable regulatory and evidence requirements.

6. Business Development and Strategic Partnerships

• Identify and evaluate strategic business opportunities, partnerships, licensing arrangements and technology collaborations.
• Develop relationships with biotechnology companies, pharmaceutical organisations, healthcare institutions, investors and research organisations.
• Support commercial negotiations, partnership agreements, technology licensing and joint development initiatives.
• Evaluate new business opportunities based on technical feasibility, commercial potential, regulatory considerations and financial viability.
• Support the CEO in developing the company's market positioning, growth strategy and long-term business development plans.

7. Financial and Resource Management

• Oversee operational budgeting, financial planning and cost management in collaboration with the finance function.
• Monitor operating expenditure, capital expenditure, cash flow requirements and departmental budgets.
• Ensure effective allocation of financial, human and technical resources.
• Establish key performance indicators (KPIs) and management dashboards to monitor operational and financial performance.
• Identify opportunities to improve productivity, reduce operating costs and maximise return on investment.
• Support financial forecasting, fundraising planning and investment prioritisation.

8. Organisational Leadership and Talent Development

• Build, lead and develop a capable multidisciplinary organisation across scientific, technical, manufacturing, quality, regulatory and business functions.
• Recruit, mentor and retain key personnel in line with the company's growth strategy.
• Establish clear responsibilities, performance expectations and accountability across departments.
• Foster a collaborative, entrepreneurial and performance-driven organisational culture.
• Promote effective communication and coordination between scientific and commercial teams.

Qualifications and Experience

Education

• Bachelor's or Master's degree in Biotechnology, Biopharmaceutical Sciences, Biomedical Sciences, Pharmaceutical Sciences, Chemical Engineering or a related discipline.
• An MBA or postgraduate qualification in business management, operations management or a related field would be advantageous.

Professional Experience

• Minimum 10–15 years of relevant professional experience in biotechnology, biopharmaceuticals, pharmaceuticals, regenerative medicine or advanced therapeutics.
• At least 5 years of experience in a senior management, operational leadership or general management position.
• Demonstrated experience in managing multidisciplinary teams and overseeing complex biotechnology or biopharmaceutical operations.
• Experience in technology development, process scale-up, manufacturing operations or commercialisation of biotechnology products.
• Familiarity with GMP manufacturing, quality management systems and regulatory compliance.
• Experience working with external CDMOs, CROs, research institutions, hospitals or strategic industry partners.
• Experience in an SME, start-up or growth-stage biotechnology company would be highly desirable.