Technical Transfer Services Specialist
This role is responsible for supporting the cGMP manufacture of biological bulk drug substance (BDS) at a leading Biopharma facility in Dublin.
Job Description
The Technical Specialist will provide processing expertise to support technology transfer, process validation, and routine commercial manufacturing for Upstream and/or Downstream manufacturing.
* Development, review, and approval of process, buffer, and media electronic batch records (eBR)
* Support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility
* Collaboration with Process Development, DS Process Sending unit (Contract Manufacturing Organisation (CMO)), Operations, Automation, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and other involved departments
Key Responsibilities:
* To provide process expertise in one or both of the following disciplines: Upstream (Cell culture focus), Downstream
* To develop, review, and approve process, buffer, and media eBR
* To author and review process transfer documentation, gap assessments, technical protocols, reports, and process validation documentation
* To identify requirements for laboratory studies to support process fit, decisions, or process transfer
* To work closely with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure availability and release of materials
* To identify and implement process improvements, yield, cycle time reduction
Requirements:
* Minimum 5+ years experience in Technical Transfer Services/Process Development/Manufacturing Support
* Technical and operational knowledge of multiple unit operations in cell culture processing
* Experience of Technology Transfer activities
* Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing