Job Description
Manufacturing & Operations Management
- Direct, plan and control all manufacturing operations to meet production schedules, product quality standards, safety requirements, and cost targets.
- Lead and develop the Production Management team to ensure reliable day-to-day operational oversight and staff performance.
- Ensure adherence to aseptic processing standards and sterile facility environmental controls.
- Manage all service providers and toll manufacturing contracts.
Maintenance & Technical Systems
- Oversee the Maintenance Department and ensure all equipment, utilities and facilities are maintained to required operating and GMP standards.
- Ensure preventative maintenance programs, equipment validation/calibration plans, and plant reliability systems are executed effectively.
Supply Chain & Materials Management
- Manage raw material sourcing, supplier performance, inventory control, cold chain/storage requirements, and finished goods release in collaboration with QA/QC and SCM teams.
Financial & Cost Management
- Develop, manage, and control departmental operational budgets, including labour, consumables, maintenance, and utilities.
- Conduct product costing, cost reviews, waste reduction initiatives, and process efficiency improvement projects.
Quality, Safety & Compliance
- Ensure operations comply with ISO 9001, cGMP, veterinary biological standards, biosafety regulations, and SOPs.
- Drive continuous improvement in aseptic technique, cleanroom behaviour, and process discipline.
Strategic & Cross-Functional Collaboration
- Provide technical and operational input into new product introduction, scale-up, and technology transfer.
- Contribute operational data and performance reports to the Managing Director as required.
Essential Knowledge / Experience (min 5 years):
- Management experience in sterile/aseptic manufacturing, preferably biopharma, vaccine, veterinary biologicals or biologics production.
- Demonstrated experience managing both Production and Maintenance teams.
- Strong technical/mechanical knowledge of facility utilities, cleanroom systems, and production equipment.
- Financial and budgeting experience including cost control and forecasting.
- Experience working in a regulated manufacturing environment (ISO 9001, cGMP, HACCP, or similar).
Qualifications:
- Bachelor’s degree in Operations Management, BPharm, Biotechnology, Microbiology, or a related scientific/technical field.
- Additional management or business qualifications are advantageous.
Key Skills / Attributes / Position Specific Competencies:
- Strong leadership and people development capability.
- Operational planning and project management.
- Critical thinking, troubleshooting and root cause problem-solving.
- Effective communication and report writing.
- Negotiation and conflict resolution.
- Competent in MS Office (Excel, Word) and ERP/MRP systems.
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