Upstream Technical Services Specialist – Pharmaceuticals
A challenging opportunity exists for an Upstream Technical Services Specialist to contribute to the continuous drive of innovation in a life-changing pharmaceutical organization.
Responsibilities:
* Upstream (Cell culture focus) including media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification)
* Author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
* 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
Required Skills and Experience:
* Minimum 5+ 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
* Experience of Technology Transfer activities is advantageous