MSAT Bioprocess Specialist

Key Responsibilities

• Lead the technology transfer of new and existing biologics processes into GMP manufacturing.
• Prepare, review, approve and issue GMP manufacturing documentation, including batch records.
• Define scale‑up criteria and develop process mass balances and flow diagrams.
• Specify large‑scale equipment and assess material suitability for GMP use.
• Generate quality documentation for raw materials and equipment.
• Work within the site Quality Management System, raising and managing change controls.
• Conduct and close investigations, deviations and CAPAs.
• Project‑manage the introduction of processes into manufacturing from end to end.
• Perform risk assessments aligned with ICH Q9 principles.
• Collaborate cross‑functionally with MSAT, Development, Manufacturing, QA, Supply Chain, Engineering and Project Management teams, as well as relevant external partners.

• BSc (Hons) or equivalent in a Science or Engineering discipline.
• Strong organisational and stakeholder‑influencing skills.
• Demonstrated project management capability and ability to meet deadlines.
• Experience in process scale‑up/transfer and providing manufacturing support.
• Effective communication across all levels.
• Experience evaluating materials for process suitability and writing GMP batch records.
• Commercialisation and process validation.
• Process improvement and process mapping.
• Defining, sourcing and validating large‑scale bioprocessing equipment.
• Effective team working
• Clear communication
• High attention to detail

You’ll play a pivotal role linking development and GMP operations, directly influencing manufacturability, compliance and the successful delivery of biologics processes- while working within a collaborative, growth‑focused environment. The company also offer an extensive benefits package.