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  • DUBLIN 2
  • Job reference number:15445108
  • Client ID:RI/SF16453
  • Posted on:15-MAY-2019
  • Location:WATERFORD
  • Job type:PERMANENT


R&D Sterile Process Lead.

Job Purpose: To support the R&D department by providing significant fill-finish technical expertise to support all aspects of the formulation & manufacturing of sterile products


As a key member of the R&D team, your role is to provide leadership, cross-functional development and technical expertise on the aseptic manufacture of sterile formulations.

In conjunction with internal stakeholders:
• Act as SME for sterile formulation of small molecule and biologic products
• Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
• Interpret in-vitro data for the purposes of further formulation development.
• Provide scientific leadership across all the disciplines involved in Sterile Operations
• SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
• Support all aspects of the manufacturing process from formulation development through to filling & lyophilisation
• Technical review of change controls for impact to product quality, safety and efficacy
• Provide on-floor technical support and troubleshooting
• Identify and then lead process optimisation initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
• Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities
• Collection, organisation, trending, and analysis of GMP manufacturing data
• Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
• Ensure information transfer to Process Engineering group for all cycle development activities
• Ensure appropriate scientific documentation is collated and approved for a robust Process Flow document
• Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy.
• Lead technical feasibility review and technology gap analysis for new product introductions
• Escalation of issues to the Sterile Technical Operations Manager, as appropriate
• Communication of project data through presentations at internal meetings and through formulation development reports.
• Provide guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities.
• Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature.

Technical expertise sought for this role:
• Extensive operational experience within aseptic filling lines and formulations areas
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Sterile filling processes and equipment
• Pharmaceutical and Biotechnology formulation & manufacturing processes
• Technical Primary pack knowledge and vendor knowledge (WEST, Schott, OMPI, etc.)
• Demonstrable analytical and systematic problem solving skills

Minimum Qualifications & Experience requirements :
• Qualified to Honours Degree level in an appropriate science discipline

Minimum 5 years’ experience in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
• Significant exposure to sterile operations and/or Tech Transfer projects
• Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing and the ability to implement best practices
• Experience of technology transfers and implementing new clinical and commercial manufacturing processes, specifically sterile liquid fill operations.
• Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes.

This job originally appeared on RecruitIreland.com