R&D Sterile Process Lead
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. Responsibilities: 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. Experience: • 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.
385 days ago