Position Details

Responsibilities
Project Planning & Execution: Coordinate TSA work package activity including developing  and implementing project plans, generation protocols, schedules and respective reports. 
Process Improvement: Lead initiatives to improve processes and implement new methods within production departments.
Troubleshooting: Manage and resolve process related issues in collaboration with R&D and production teams.
Technology Transfer: Oversee the transfer of new products from development to production, transfer and scale up of existing products including risk management and coordination activities. Ultimately own and deliver successful Tech Transfer reports.
Process Validation: Plan, execute, and analyze process validation activities in accordance with regulatory and quality requirements, including protocol preparation and reporting. Provide critical focus for process validation readiness including setting clear validation  objectives, define process parameters and measurements (such as IPCs, CPPs, CQAs), and monitor project progress.
Engineering Support: Support Engineering to generate and deliver approved lifecycle managed user requirements specifications (URS). TSA Referent will confirm process parameters including necessary ranges for URS’s.
Cross Functional Collaboration: Work closely with Engineering, Production, Quality Assurance, Regulatory and as required R&Ddepartments to ensure project success. Manage the interface with Operations team to ensure manufacturability is maintained during design whilst also enabling operational readiness activities during handover and startup.
Data Analysis & Documentation: Analyze process and production data to identify trends, support decision making, and drive continuous improvement. Prepare, analyze, summarize, and conclude protocols and reports in line with regulatory and quality standards.
Interface and Knowledge Management: Coordinate with Site TSA teams to capture and share knowledge, keep informed throughout project lifecycle, coordination via clear expectations and timelines for when Core TSA resources need to support project execution.

Requirements
Education: M.Sc. or higher in Life Sciences, Biotechnology, or Veterinary Medicine (mandatory). Note B.Sc. In life sciences subject matter with 8-10 years relevant experience or Ph.D with 3years relevant experience will be assessed.
Experience: minimum of 5 years in one or more of the following roles : 
Process Scientist in biotech or vaccine production
Department Manager in Production
Process Engineer in a pharmaceutical or biotechnology company
R&D Researcher in a pharmaceutical company
Skills: 
Proven ability to analyze data, and to write clear protocols and reports.
Demonstrated accountability and experience in leading projects end to end in a multi disciplinary environment.
Strong ability to read and interpret scientific literature.
In depth knowledge of production processes, diagnostic methods, and state of the art technologies.
Project management capabilities is highly beneficial.
Experience in process transfer and process validation is a must.
Experience in cleaning validation including cycle development is highly beneficial.
Experience in the execution and or support for qualification activities form URS through to qualification is essential.
Technical communication to all levels within an organisation, technical and non-technical is a must. 
Aseptic processing and operations process experience is highly beneficial.
High proficiency in English (spoken and written).