LSC have a great contract opportunity for a QC Microbiology Manager to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have 5+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead the QC Microbiology team to operate in compliance with current cGMP standards at all times, ensuring samples are tested and results delivered within specified timelines.
- Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
- Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
- Own and provide oversight for sterility testing program on site related to the Drug Product Facility onsite.
- Manage external microbial testing and relationships with external testing labs and suppliers.
- Develop the team in areas of technical expertise, use of operational excellence tools and high-performance team behaviours, including standard work, 5S and lean laboratory practices.
- Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in a Science-related field required
- 5+ years of biopharmaceutical QC experience, or related Quality Control/GMP laboratory experience within the pharmaceutical or medical device industry, is preferred.
- Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations for microbiological control, environmental monitoring and aseptic processing.
- Previous experience of managing the performance of individual team members and of the overall team, including development and succession planning.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Amy Smyth at LSC on 021 4777329 if you have any more questions about this role!
