Shift Pattern: Two days (07:00-19:00), two nights (19:00-07:00), followed by four days off
Provide leadership and technical support to manufacturing operations, ensuring all standards are met and continuous improvement is driven across all development and manufacturing activities.
- Operational leadership - Support manufacturing teams to maintain compliant, efficient operations
- Customer & supplier liaison - Engage with internal and external stakeholders to optimise operational performance.
- Process optimisation - Identify, evaluate, and implement improvements across manufacturing and development operations.
- Capital project support - Assist in planning and implementing capital projects.
- Inspection process lead - Act as process lead for inspection development activities.
- Technical problem‐solving - Lead root cause analysis and technical issue resolution with cross‐functional teams.
- Performance monitoring - Implement and track key performance indicators.
- Cycle‐time reduction - Drive initiatives to reduce process cycle times.
- Best‐practice implementation - Embed industry best practices across operations.
- Process development - Design, execute, and implement process development programmes and plant trials.
- Continuous improvement - Challenge existing standards and promote ongoing improvement.
- Quality documentation - Maintain all required quality documentation in a compliant state.
- New product introduction support - Act as SME for new product introduction and enhancement projects.
- Clinical supply support - Provide technical support for clinical supply provision projects.
- Aseptic manufacturing context - Support operations within aseptic manufacturing environments.
- Product & process SME - Serve as SME for product quality attributes and critical process parameters.
- Experimental programme design - Design and execute experimental studies.
- Process laboratory operation - Operate and support process laboratory activities.
- Scale‐up & tech transfer - Support scale‐up and technology transfer projects.
- Cross‐functional liaison - Liaise with teams involved in formulation, enhancement, and clinical supply.
- Quality system support - Support complaints, LCRs, deviations, and CAPAs, ensuring effective RCA and timely closure.
- SMART goal delivery - Achieve defined SMART goals.
- GMP compliance - Ensure adherence to cGMP at all times.
- Degree in Chemical, Industrial, or related Engineering discipline.
- Advanced degree in Pharmaceutics, Pharmacy, or related scientific field is an advantage.
- Aseptic manufacturing expertise - Technical knowledge of aseptic processing; lyophilisation experience is an advantage.
- Design of Experiments and associated statistical techniques.
- Pharmaceutical development lifecycle.
- Strong report writing and communication skills.
- Laboratory and pilot‐plant capability.
- Research, innovation, and creativity skills.
- Project management capability.
- Structured problem‐solving using statistical tools.
