Job Reference: FRS29994
Job Duration:
Start date: 23/01/2019
Description:
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 thecompany'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 rawmaterial specifications, e.g., cell culture media, chromatography resins and excipients
* Perform Bill of Materials Assessmentfor new materials introduced to the site and source alternative vendors and suppliers when needed
* Support Analytical methodtransfers 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-TechnicalSpecialist 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 6years 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
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Please contact Felicity Farrell on 086 7821714 for more information on this Technical Specialist JobCork
Industry: Science and Research
Salary: €60000 - €70000 per annum + Healthcare, Pension, Bonus
Salary Benefits: Healthcare, Pension, Bonus
Vacancy Type: Permanent
Job Skills: Technical Biologics specialist job Cork, Materials Scientist, Technical Specialist job Cork, Materials Scientist job Cork
Contact Name: Felicity Farrell
Website: -
Direct Application URL: -