Pharmaceutical Process Development Specialist
Are you looking for the chance to join a life-changing organisation in their mission to continuously drive innovation?
Located near Dublin Airport and just a short distance from the lively Irish capital, this leading biopharmaceutical company paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility.
Job Description:
Our team is seeking an experienced Pharmaceutical Process Development Specialist to support our upstream operations. This role will focus on cell culture processing, including media preparation, large-scale cell culture bulk drug substance manufacturing processes, and process transfer documentation.
Responsibilities:
* Support upstream operations, focusing on cell culture processing
* Author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation
* Identify requirements for laboratory studies to support process fit decisions or process transfer, and liaise closely with Global Process Development to oversee the design and execution of studies
* Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications, and outline testing requirements
* 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
* Identify and implement process improvements, e.g., yield, cycle time reduction
Requirements:
We are looking for an individual with a minimum 5+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation. The ideal candidate should have technical and operational knowledge of multiple unit operations in cell culture processing, as well as comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing. Experience of Technology Transfer activities is advantageous.