back to search results


  • DUBLIN 2
  • Job reference number:15432955
  • Client ID:RI/AM16453
  • Posted on:15-MAR-2019
  • Location:WATERFORD
  • Job type:PERMANENT

R&D Sterile Formulation Lead - County Waterford.

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 five 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