The posting
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.
