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. In the recent past, 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 Microbiology to join the organisation at this early stage in the site's development.
- Reporting to the Head of Quality Control, the QC Microbiology Lead - Associate Director 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 product testing and Environmental Monitoring teams. Working closely with 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.
- Key member of the QC leadership team and will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
- Work closely with all leaders to ensure work practices and targets are achieved in line with the business targets and objectives.
- The role will require extensive liaison with counterparts and business leaders at corporate to include the highest level of professional representation of the local site QC organisation.
- From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
- Provide the highest quality microbiological support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
- Degree qualified in a related Science discipline or equivalent.
- Demonstrating direct experience as QC Micro Lead in regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.
- Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including bioburden and endotoxin testing, sterility testing and microbial identification, etc. to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements.
- Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
- Ability to think critically and demonstrate troubleshooting and problem solving skills.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.