Technical Specialist Biologics -Cork

Job Overview

Technical Specialist required to support the Large Molecule API technical team in this global biologics company in Cork.

Responsibilities - Technical Specialist Job
* Collaborate closely with the Material Science group based in the company's sister site in the US and guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria.
* Collaborate with raw material suppliers within Ireland and Europe to establish effective control strategies based on understanding and importance of raw material in API manufacturing
* Contribute towards developing raw material specifications, e.g., cell culture media, chromatography resins and excipients
* Perform Bill of Materials Assessment for new materials introduced to the site and source alternative vendors and suppliers when needed
* Support Analytical method transfers by coordinating testing with Europe based Analytical labs
* Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
* Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
* Support supplier audits as required
* Identify and coordinate analytical characterisation with the internal and external labs and perform testing as applicable


Requirements-Technical Specialist Job


* A BSc in a Science subject, Materials Science, Chemistry, Engineering or a related field, with at least 9 years of experience or a MSc in in a Science subject, Materials Science, Chemistry, Engineering or a related field with at least 6 years of experience or Ph.D. with at least 2 years of post-doctoral experience is essential
* Proficiency in functional characterisation of cell culture media including cell culture performance evaluation using stationary, shake flask, automated cell culture systems, and/or bioreactors is required
* Demonstrated proficiency in the analytical characterization of cell culture media and materials utilized in upstream processes and downstream processes is preferred
* Experience in qualification of cell culture media and raw materials is strongly preferred


This position will be based in Ringaskiddy in Cork but may occasionally require travel to Europe and USA


Keywords: Technical specialist job Cork, Senior Technical Specialist Job Cork, SENIOR BIOLOGICS TECHNICAL SPECIALIST - CORK, Materials Scientist job Cork, Technical specialist job Cork, Senior Technical Specialist Job Cork, SENIOR BIOLOGICS TECHNICAL SPECIALIST - CORK, Materials Scientist job Cork,

Please contact Felicity Farrell on 086 7821714 for more information on this Technical Specialist Job Cork

Key Contact

Apply Today

* indicates required field