R&D Sterile Process Lead

ICDS Recruitment

Waterford

R&D Sterile Process Lead - County Waterford. Job Purpose: To support the R&D department by providing significant fill-finish technical expertise to support all aspects of the 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 biologics. • 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 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. • 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 ensures 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. • Oversee execution of technical studies and associated document preparation at the receiving unit. • Lead technical feasibility review and technology gap analysis to ensure process / method fit within RU technology capabilities. • Monitor performance of the transferred process/method. • Study process operation and requirements at SU. • Responsible for successful receipt and documentation of transferred knowledge. • Escalation of issues to the Program Lead & Technical Development Manager, as appropriate. • Approve validation protocols that will be used as part of technology transfer, as appropriate. Technical expertise sought: • 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 manufacturing processes. • Experience in cycle development of CIP/SIP/VHP cycles. • Technical Primary pack knowledge and vendor knowledge (WEST, Schott, OMPI, etc.) • Proficiency in Microsoft Office and job related computer applications required. • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. • Strong team skills, including ability to coach/develop work teams. • Excellent training, facilitation and assessment skills. • Strategy planning and development. • Demonstrable analytical and systematic problem solving skills. • Effective time management and multi-tasking skills. Minimum Qualifications & Experience Qualifications: • Qualified to Honours Degree level in an appropriate science or engineering discipline, preferably Biotechnology. Experience: • 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 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. This job originally appeared on RecruitIreland.com.

2291 days ago