Bristol Myers Squibb QC Technical Lead (Raw Materials) in Mulhuddart, Ireland
Bristol-Myers Squibb is currently building a new state of the art large-scale biologics manufacturing facility in Cruiserath, Dublin 15, approximately $1 billion investment. Once completed, the new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.
Cruiserath Biologics are seeking to recruit a QC Technical Lead Raw Materials. Reporting to the QC Associate Director in the QC Site Operations team, the Technical Lead will provide technical expertise and oversight to the QC Raw Materials Testing group.
The Technical Lead will develop and maintain the Raw Materials Testing Programs, testing activities, ensuring compliance with regulatory and corporate directives for the QC Raw Materials laboratory that support the Large Scale Cell Culture (LSCC) DS facility and Global Release testing for the Global Biolab at Cruiserath.
They will also provide technical leadership and guidance to the QC Site Operations team on the establishment of the laboratory procedures and practices, quality system elements, method transfers, equipment qualifications, and cross-functional Raw Material Testing support for the LSCC/Warehouse facility. Technical expertise should include; HPLC, GC, FTIR, UV, TOC and general Raw Material laboratory techniques. Experience with laboratory data systems, LIMS, electronic notebook and CIMS would be an advantage.
Main responsibilities for this position include;
Oversee the Testing Program to ensure compliance
Participate in regulatory audits as the Raw Material Testing SME
Participate in laboratory investigations to ensure timely close-out
Establish communication channels between all stakeholders to ensure visibility on end-to-end process.
Participate in cross-functional teams to support Raw Material and Batch release.
Participate in definition and establishment of the laboratory Quality Systems and Operational processes
Participate in troubleshooting complex laboratory testing issues
Qualifications and Experience required:
A minimum of a B Sc. in Chemistry or related discipline and must have at least 5 years hands on experience in a Biopharmaceutical setting.
Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations.
Proven experience of providing technical leadership and guidance in a team based collaborative environment through previous roles or assignments.
Must demonstrate a problem solving ability, as well as the ability to prioritise objectives from multiple projects. Excellent communication and the ability to contribute to and lead in a team based collaborative environment is essential.
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