This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Biopharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site which once built, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for an Associate Director Quality Control - Separations to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
Reporting to the Head of Quality Control, the QC Associate Director of Separations will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility for the management of separations product-testing teams, including HPLC, CE, and cIEF. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.
- University degree in related science/quality discipline required
- Ph.D. with 5-8 years of experience, or Masters with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology or other related field, desired
- More than 10 years working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required
- Management/supervision of personnel with particular attention to schedules and shifting priorities is required and demonstrated leadership skills
- Previous experience in a Quality Control/GMP environment is required
- Previous experience with regulatory inspections and internal/customer audits is strongly preferred
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.