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QC Materials Technical Lead - Sample Management
QC Materials Technical Lead – Sample Management
Hybrid Role
An opportunity for a QC Materials Technical Lead (Sample Management) has arisen to join the QC Materials Management of a leading Dublin based Biotech multinational. The successful candidate 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.
Key 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 the site.
• 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.
Qualifications & Experience
• A minimum of a B.Sc. in Biochemistry or related discipline and must have 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.
Important that the candidate can demonstrate good project management abilities, proven decision-making ability and the ability to work well with and influence all levels of management and staff.
For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)