Senior

Description:

The Senior Principle Bioprocess Scientist - TS/MS will be responsible for providing technical support for the introduction of manufacturing processes into the upstream operations/manufacturing environment in Limerick through the startup and into routine manufacturing operations. The position will provide technical leadership and mentoring to bioprocess scientists and serve as a point of cross functional integration for the online process teams. The successful applicant will have a deep technical expertise in upstream bioprocessing and a strong skillset in data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and process improvements. They will maximize the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.

Key Responsibilities
 

• Have an in-depth knowledge of the science of upstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes
• Understand purpose and capability of each Unit Operation and the impact of equipment on the process
• Serve as a technical leader for the online process support team for process science, operational excellence and compliance
• Work as part of a cross-functional team at the interface between quality assurance, operations and engineering to bring deep technical expertise and scientific rigor to the team
• Utilize process monitoring tools to make data driven decisions to ensure process consistency and robustness
• Understand basic statistical methodologies engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews
• Develop capability in use of statistical and programming software (e.g. JMP, Python, SIMCA) to apply a broad range of data science and statistical applications, such as, DoE, multivariate analysis, and statistical modelling
• Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation
• Identify process improvements and participate in implementation of Lean Manufacturing initiatives
• Generate scientific reports and technical documentation
• Understand and ensure compliance with safety, compliance, and regulatory expectations
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies
  
   

Basic Requirements

PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Microbiology, Analytical Science, Biochemical Engineering, or related discipline with 7-10 years' relevant experience within the biopharmaceutical industry.