Process Lead - Sterile
Process Lead - Sterile: County Waterford. This role sits within the Research & Development team who are in the process of working with a new line of products. The role is to provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations. This role would suit candidates with biotechnology academic attainments, at least 5 years’ experience in working within sterile operations/tech transfer and fill-finish manufacturing. The role: • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations. • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure. • SME for sterile formulation of biologic products. • Support all aspects of the manufacturing process from formulation and filling to visual inspection. • 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. • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process. • Assist the team with development of objectives and ensure alignment with site goals. • Assist the Program Lead to generate and execute a Technology Transfer Master Plan. • Responsible for ensuring availability of knowledge, information, expertise and training as needed for the activities necessary to execute the transfer and all testing to support the Technology Transfer process, as relevant to the Receiving Unit. • In association with the Sending Unit Technical Lead define the risks, gaps and closure plans. • Lead the pre-GMP line activities (Development, Pre-Eng, Eng Run, as applicable) along with all associated protocols and reports. • Ensure information transfer to Process Engineering group for all cycle development activities. • Review sampling plans for all activities and ensure compliance with all TT requirements. • Support the generation of the Control Strategy. • Ensure appropriate scientific and engineering 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. Interested applicants should have: • An honours degree in Science/Biotechnology (or a related discipline. • At least 5 years’ experience in the following areas: o 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 biopharmaceutical manufacturing and the ability to implement best practices. • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations. • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes. • Self-starter who enjoys working in a fast paced environment. This job originally appeared on RecruitIreland.com.
135 days ago