Technical Support Analyst

Description:

Responsibilities

• Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.
• Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
• Coordinate technical deliverables within Drug Substance to support the successful product launch.
• Provide technical support to the operations team's during commercial manufacturing.
• Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
• Support Batch Disposition activities by providing SME technical support for comment resolution.
• Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.
• Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
• Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
• In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organisation.

Requirements

• Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
• Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Experience in data driven approach to root cause analysis and prioritisation of continuous improvement initiatives e.g., Six Sigma
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA
• Ability to adapt to changing priorities as project demands change