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Leading global Biopharmaceutical Company focusing on transformative solutions within Neuroscience, Oncology and Rare Disease is currently recruiting for a Production Development 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 teamSkills 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 levelsApply now for more information