Technical Services Specialist

• Support Process Transfer activities.
• Lead any key process changes using change control system
• To identify and implement process improvements, e.g. yield, cycle time reduction
• To provide process expertise in either Upstream or Downstream Bioprocessing.
• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
• To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
• To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
• To author and review process transfer documentation, gap assessments, technical protocols and reports, process validation documentation, and strategy documents. Also generate documentation protocols.

• Experience of Technology Transfer activities
• Knowledge or experience of start-up or systems would be ideal
• Technical and operational knowledge of upstream or downstream processing.
• Previous experience working with electronic batch records is advantageous.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
• Ability to drive for results independently and adapt to rapidly changing priorities
• Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization

This is a hybrid contract, 3 days per week on site.