Technical Development Specialist

12 hours ago


Linton, United Kingdom Adepto Technical Recruitment Ltd Full time
MSAT Technical Specialist

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:

  1. Draft, write and review process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.
  2. Draft, write, and review Technology Transfer documentation for any processes being used for fill-finish.
  3. Collaboratively improve and/or troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation.
  4. Review GMP material assessments and bill of materials for use in manufacturing.
  5. To be the technical author of deviation impact assessments which feed into the Quality Management System.
  6. Risk analysis of processes including prioritisation and implementation of mitigations.
  7. 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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