EirGen Pharma have a new opportunity for an R&D Sterile Formulation Lead to join their R&D Team. The purpose of this role is to support the R&D department by providing significant fill-finish technical expertise to support all aspects of the formulation and 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 sterile formulations.
Responsibilities of this role include:
In conjunction with EirGen’s internal stakeholders:
- 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 optimization 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.
- 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
The ideal candidate for the role will meet the following criteria:
- 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.