MSAT Technical Specialist

MSAT Technical Specialist
Permanent role
Location: Cambridgeshire
Salary: 55,000
Benefits: Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, Bonus & more

An exciting opportunity for an establishedMSAT Technical Specialisthas arisen to join a global leader in contract manufacturing for medical device, diagnostics, and drug delivery.

You will be responsible for the development and improvement of manufacturing processes, creating quotations for process development & manufacturing work, as well as supporting with technical troubleshooting of Fill Finish Processes.

As theMSAT Technical Specialistyour role will be varied and exciting. You will collaborate access departments and support customers when necessary. You will also be responsible for:

• Draft, write and review process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.
• Draft, write, and review Technology Transfer documentation for any processes being used for fill-finish.

• Collaboratively improve and/or troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation.

• Review GMP material assessments and bill of materials for use in manufacturing.
• To be the technical author of deviation impact assessments which feed into the Quality Management System.
• Risk analysis of processes including prioritisation and implementation of mitigations.
• IP generation and review.

To be considered for theMSAT Technical Specialistrole, you will have a keen eye for detail, a strong communicator who is able to manage multiple tasks at one. You will also have most of the following:

• BSc/MSc in Biology, Pharmaceutical Science, Biotechnology, Biomanufacturing, or similar.
• Previous relevant Process Development/MSAT function experience.
• Experience working within cGMP manufacturing environments.
• Knowledge of manufacturing process design, scaling, and characterisation.
• Knowledge of QbD, DoE and statistical process control methodologies.
• Manage CMOs and Suppliers in technical and project planning activities for process development, technology transfer and validation.
• Validation activities including specification writing, qualification testing and reporting.
• Lead/Manage elements of technology transfer into cGMP production.
• Experience working under the ISO13485 and GMP quality systems.
• Experience in risk assessment and risk management.

If you want to find out more, please apply now!