Technical Development Specialist
12 hours ago
We are seeking an experienced MSAT Technical Specialist to join our team at Adepto Technical Recruitment Ltd.
The successful candidate will have a strong background in manufacturing process development and improvement, with experience in creating quotations and supporting technical troubleshooting.
Key Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- A competitive salary of £55,000 per annum, depending on experience.
- A dynamic and supportive work environment.
- Ongoing training and development opportunities.
- A comprehensive benefits package, including private medical cover and enhanced leave policies.
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