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Barden are delighted to be supporting our Global Biopharmaceutical client in their search for a Technical Services Specialist for their state-of-the-art facility in Dublin.
The Technical Services Specialist is primarily responsible for supporting the cGMP manufacture of biological bulk drug substances. This role involves providing processing expertise to aid in technology transfer, process validation, and routine commercial manufacturing for Upstream processes.
Additionally, the Technical Specialist will support the technology transfer of new and existing drug substance (DS) manufacturing processes. This requires close collaboration with various departments, including Process Development, DS Process Sending Unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and others, to ensure successful facility startup and process qualification.
ABOUT THE ROLE:
Principal Responsibilities
- To provide process expertise in:
- 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.
- 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 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
- 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.
ABOUT THE PERSON
Qualifications:
- B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
- Minimum 3+ years’ experience in Technical 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
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
