Senior Technical Transfer Specialist
20 hours ago
Technical Transfer Services Specialist required to support the cGMP manufacture of biological bulk drug substance (BDS) for a leading Biopharma facility in Dublin. Initially a 12 month contract. Please contact Claire The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Technical Specialist will be responsible for development, review and or approval of process, buffer and media electronic batch records (ebr), providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit (i.e. Contract Manufacturing Organisation (CMO)), Operations, Automation, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability. Role: To provide process expertise in one, or both of the following disciplines: Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification. Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill. To develop, review and or approve process, buffer and media electronic batch records (ebr) To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development and CMOs to oversee the design and execution of studies To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines To identify and implement process improvements, e.g. yield, cycle time reduction To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution Lead any key process changes using change control system Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations To author and review common technical document (CTD) sections and reports for regulatory agency submissions To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing Requirements: Minimum 5+ years experience in Technical Transfer Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization Technical and operational knowledge of multiple unit operations in cell culture processing Experience of Technology Transfer activities is required Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings Ability to present and defend technical and scientific approaches in both written and verbal form Ability to drive for results independently and adapt to rapidly changing priorities Knowledge or experience of start-up or systems would be ideal Detail orientated Technical writing competency Education B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. Experience of authoring CMC sections of regulatory submissions Skills: Technical Transfer Services Specialist Process Validation EBR Process Engineering
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Senior Technical Transfer Specialist
1 day ago
Dublin, Ireland Claran Consultants Ltd Full timeTechnical Transfer Services Specialist required to support the cGMP manufacture of biological bulk drug substance (BDS) for a leading Biopharma facility in Dublin. Initially a 12 month contract. Please contact Claire The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial...
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Technical Transfer Scientist
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Dublin, Ireland CareerWise Recruitment Full timeA Technical Transfer Engineer is required by CareerWise Recruitment for a Biotechnology client. This is a 12-month contract. Must Have Drug Product Biologics Monoclonal Antibodies Technical Transfer Experience and for this role . This position is a remote based position with travel to mainland Europe. THE ROLE: Work with External Partners to achieve business...
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Technical Services Specialist
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Dublin, Ireland TEAM HORIZON Full timeTeam Horizon is seeking a Upstream or Downstream Technical Services Specialist for our client Dublin. The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS). The Technical Specialist will provide processing expertise to support routine commercial manufacturing, technology...
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Technical Services Specialist
1 day ago
Dublin, Ireland Tandem Project Management Limited Full timeSummary: A Technical Services Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and Downstream manufacturing. The incumbent will be responsible for development,...
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Technical Services Specialist
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Dublin, Ireland Tandem Project Management Limited Full timeSummary: A Technical Services Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and Downstream manufacturing. The incumbent will be responsible for development,...
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Dublin, Ireland PE Global Full timePE Global is currently recruiting for a Senior QA Specialist for a leading multi-national Pharma client based in Dun Laoghaire. NPI and Tech Transfer experience essential for this role This is a contract position. Role: Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes,...
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QA Specialist
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Dublin, Ireland PE Global Full timePE Global is currently recruiting for a Senior QA Specialist for a leading multi-national Pharma client based in Dun Laoghaire. NPI and Tech Transfer experience essential for this role This is a contract position. Role: Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes,...
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Technical Transfer Project Manager
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Dublin, Ireland Recruitment by Aphex Group Full timeTechnical Transfer Project Manager Purpose The role of New Product Introduction (NPI) Manager is responsible for the program management including scope, budget, schedule and delivery for the Technology Transfer and introduction of a new product, drug substance, drug product, Medical Device and Finished Packaging either to an internal site or an external CMO...
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Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Plant and Technical QA Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next...
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[3 Days Left] Technical Transfer Scientist
3 days ago
Dublin, Ireland CareerWise Recruitment Full timeA Technical Transfer Engineer is required by CareerWise Recruitment for a Biotechnology client. This is a 12-month contract. Must Have Drug Product Biologics Monoclonal Antibodies Technical Transfer Experience and for this role . This position is a remote based position with travel to mainland Europe. THE ROLE: Work with External Partners to achieve business...
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Dublin, Ireland CareerWise Recruitment Full timeA Technical Operations Specialist is required by CareerWise Recruitment for our Irish based pharmaceutical client. Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture within our External Manufacturing Network in Europe. This is a remote position based in...
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Dublin, Ireland Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
