This innovative speciality biotech organisation is a leading science-based biopharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. This includes medicines for eye diseases and a rare inflammatory condition. In addition it has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. Employing north of 10,000 staff globally with annual R&D spend north of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally year on year.
- Working with QC, Manufacturing, Facility Maintenance and Engineering departments to consistently improve the general facility contamination control program and support remediation efforts where necessary.
- Supporting investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plan determination and remediation plans. Work in conjunction with the directors of the affected department to achieve these goals.
- Supporting investigations, document reviews and continuous improvement opportunities relating to microbial control and compliance.
- Maintaining industry standards with respect to microbial control and mitigation - incorporate any new industry standards/use of new monitoring equipment into the IOPS system.
- Provides input on technology transfer plans related to microbiological method transfers (method validation).
- Supporting IMT with inspection preparations and regulatory inspections.
- Reviewing and providing input on the development and modification of microbial action limits.
- Evaluating and giving input on microbiology SOPs, microbiology assay validation and related documentation.
- Reviewing and providing input on environmental monitoring SOPs and environmental monitoring protocols.
- Reviewing and providing strategic support to understanding and leading excursion trend levels.
- Reporting excursions trends and their interpretation to senior management.
- Responsible for assessing the efficiency of IOPS sanitization agents.
- You will hold a MS/BS degree in microbiology, medical technology, biology or related field.
- Have 12 years' experience (Director Level or similar) or 15 years experience plus (Senior Director level) in the pharmaceutical or biotechnology industry.
- Have the required experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.