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This job specification outlines the general responsibilities associated with the role of Manager QC Separation Sciences (QCSS) at Amgen Dun Laoghaire. This role will be responsible for managing the Separation Sciences and in-process team while owning, facilitating, and undertaking activities pertaining to QCSS within QC. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QCSS duties and testing, including release/stability/in process of commercial product. The role also represents the QC unit by liaising with internal and external stake holders
Job Responsibility:
Supervision/Management of QC Separation Sciences including In-process team
Ensure the Separation Sciences area is operated in a safe manner
Ensure all testing is performed in accordance with relevant procedures and within the required due date
Develop, revise and implement procedures that comply with appropriate regulatory requirements
Out of hours responder for Separation Sciences equipment (fridges /freezers / incubators)
QC Representative for Separation Sciences at Amgen network meetings
Developing and coaching the QC Separation Sciences team
Ensure timely completion of lab investigations and deviations through the relevant procedures
Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to Separation Sciences
Participate in regulatory agency inspections as required
Manage and contribute to the achievements of department productivity and quality goals
Conduct performance appraisal reviews for staff and identify training requirements for further development of colleagues
Requirements:
Bachelor’s degree in a Science related field is required
6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
2 – 3 years of specific QC laboratory management experience is desirable
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating
Proven experience of leading teams
Broad technical knowledge within Separation Sciences area
Specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role
Experience leading cross-functional teams is desirable
Nice to have:
Specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage
Experience leading cross-functional teams is desirable