NPD Project Coordinator

Salary: £36,000 – £42,000 per year

Benefits include:

• Holidays = 25 days + 8 statutory Bank Holidays
• Pension = 10% employer contribution min 5% employee contribution
• Death In Service (4 times salary if in pension)
• Private Health Insurance (if you can no longer work through ill health)
• AXA Health insurance (single cover)
• Subsidised Restaurant
• Paid 30 mins. lunch break
• General Hours = 08.30 – 16:30
• Employee Assistance Programme (free confidential help line for any issue)
• Cycle to work
• Doctor at Hand – Telephone GP service
• iBenefits – Discounts for all major retailers
• Sports subsidy of £350 per annum

Global Biopharmaceutical Company leading the focus on transformative solutions within Neuroscience, Oncology and Rare Disease is currently recruiting for a NPD Project Co-ordinator.

About the role:

To coordinate and drive activities that support the technical transfer of new products into Production Operations. This will include transfer of Production activities, such as media and reagent preparation, upstream and downstream processing and activities that support the cleaning and maintenance of the facility.

Working with the Tech Transfer team, the individual will utilise prior experience in a GMP role to ensure full compliance of manufacturing with cGMP and regulatory standards.

The individual will generate training packages (TRMs) and be trained in technical aspects of the specialised manufacturing process. Critically evaluating each process step to identify, lead and drive improvements in all key strategic areas (Cost, quality, delivery, process) as part of the development phase, transfer phase and GMP manufacturing phase.

Duties may include:

• Learn the ‘end to end’ process and be able to support with developing the process in readiness for GMP transfer
• Develop documentation to support manufacture in a GMP environment.
• Lead problem solving initiatives for manufacturing investigations within processes, ensuring
• meaningful Corrective/Preventative actions are assigned to drive improvement and alignment with GMP
• and regulatory standards.
• Participate in process development, monitoring and data gathering to drive analysis and improvements
• To lead and deliver Continuous Improvement activity in support of the objective to deliver a compliant GMP process
• To coordinate and train team members in the manufacturing process, to ensure GMP batches can be made in a safe and compliant manner
• Review, Edit and preparation of SOPs for processes
• Identify, liaise, and work with third parties to facilitate the tech transfer of process
• Creation and review of protocols and reports
• Function effectively as part of a cross functional team to deliver project milestones on time and business objectives
• Deliver the tech transfer project in conjunction with different stakeholders as part of a cross functional work team

Skills and experience:

• Graduate in an appropriate Science discipline
• Lean Six Sigma – desirable
• Scientific, Quality or Biological manufacturing background.
• IOSHH or NEBOSSH certification desirable.
• At least 3 year’s manufacturing/technical experience and competency associated with cGMP Manufacturing Operations
• Competent in GDP
• Know what ‘good looks like’ to ensure regulatory and procedural (local) compliance
• Experience with Trackwise, Change controls
• Proficient in writing GMP documentation
• Continuous improvement experience
• Willingness to learn and develop drug substance manufacturing knowledge (eg upstream and downstream manufacturing / Media prep)
• Excellent verbal and written English skills are essential for the effective communication of ideas, concepts, report writing and communication with all levels

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