QC Bioanalytical Sciences: QC Specialist
An opportunity has arisen within a leading Dublin based biopharmaceutical multinational for a QC Specialist on the Bioanalytical team. The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time.
• Expert in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Experience of managing project groups and leading high performing teams and delivering results
• Qualification of analytical equipment and related testing functions.
• Co-ordinates & plans activities related to the successful method transfers and optimisation of Bioanalytical Methods into the Amgen site.
• Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
Qualifications and Experience:
• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 5-7 years of experience in a pharmaceutical/healthcare Laboratory.
• Proven experience of leading teams.
• Strong background in Bioassays, Immunoassays and Cell Culture is essential.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.