New opportunity available to join our client’s QC Materials Management team at its Multi-Product Cell Culture Drug Substance Facility in Dublin. The QC Materials Technical Lead (Sample Management) will have responsibility for the development and oversight of the sampling and analysis plans for the Biological Drug Substance samples produced via the Multi-Product Cell Culture (MPCC) and Drug Product samples produced via the Sterile Drug Product (SDP) facility, the development and implementation of site strategies in support of sample management lab programs in addition to providing technical expertise and guidance to relevant site functions in accordance with cGMP regulations.
Responsibilities:
• Develop, maintain and oversee the sample management lab programs for the Drug Substance and Drug Product facilities.
• Oversee the QC VMI program, driving a lean capacity and keeping expiry losses at a minimum.
• Manage the inventory storage strategy of training samples and the Reference Standard Critical Reagent program for QC, supporting continued training, commercial testing and business continuity.
• Provide technical expertise in areas such as sample processing activities, Drug Substance & Drug Product Sampling, retain program management & sample lifecycle controls.
• Provide technical leadership and guidance to the QC Sample Management team on the establishment of laboratory procedures and practices, quality system elements, equipment qualifications and cross-functional sample management support across Cruiserath Biologics.
• Support continuous improvement initiatives for the sample management lab by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
• Support the review and approval of Material Science & Technology (MS&T) Drug Substance & Drug Product study protocols & reports as the Sample Management subject matter expert (SME).
• Support technical transfer activities for new product introduction.
• Provide SME support on QC, Manufacturing and Warehouse investigations involving QC sample components, including impact assessment, root cause analysis and Corrective/Preventative Action generation.
• Participate in and support audits, both internal and external (HPRA/FDA etc.) Act as the primary point of contact for audit discussions relating to sample management.
• Build and foster strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. Collaborate with network sites on technical issues to drive and maintain an aligned quality approach and foster an environment of continuous improvement.
Qualifications:
• A minimum of a B.Sc. in Biochemistry or related discipline with at least 5 years’ experience, in a GMP laboratory setting with sample management experience.
• Knowledge of cGMPs pertaining to sample management.
• Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable.
• Demonstrated ability to influence work cross functionally in a dynamic and challenging environment.
• The candidate must have experience in electronic systems such as LIMS/CIMS, Trackwise/Infinity and SAP.
• Demonstrated experience in corporate and regulatory audits.
• Planning and organisation skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities in a dynamic work environment.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
The candidate will have demonstrated good project management abilities, proven decision-making ability and the ability to work well with and influence all levels of management and staff. Additionally, the successful candidate must be able to interact with a broad range of disciplines and exert positive influence within internal matrix teams across a variety of functions.
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