Head Of Technical Services - Biologics
This company is one of the world's leading biopharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts more than 20,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to meet significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today and building their pipeline through research and development and business development delivering access in the future for patients. Due to continued expansion in Ireland and investment into a new mAb's D.S manufacturing plant here in Ireland, a new requirement has arisen for a "Head of Technical Services" to join this green field manufacturing plant. The Position. Define, coordinate and drive completion of technical work packages with functional representation for process/analytical development, laboratory services and process/analytical validation. Closely coordinate technical deliverables/input to meet Project timelines for design, facility start up, process validation and CMC product registration. Primary technical contact with the project team, product teams, PDTS leadership/steering team and other key stakeholders including Quality and CMC Regulatory Affairs. Joint responsibility with Tech Transfer Lead to establish and manage Tech Transfer activities with coordination across PDTS technical teams and activities. Manage PDTS project/functional budgets and resources to complete technical work packages and routine TS operations. Establish and manage TS team inclusive of hiring, training and colleague development to deliver TS activities including product transfers, site start-up activities and routine manufacturing support. The Person. A BSc in Biochemistry/Protein Chemistry or Chemical Engineering or related discipline with relevant work experience. Technical expertise with Biologics drug substance process development and/or manufacturing operations. Experience of bioprocess facility design and start-up. Experience leading process technology transfers for clinical/commercial biologics (s. To learn more apply online or contact Shane Browne at HRM on 353 1 632 1865. This job originally appeared on RecruitIreland.com.
Dublin North, Dublin
109 days ago