LSC are resourcing BioProcess specialists to work in a high-performing, team based biotech manufacturing organization based in Cork.
The Bioprocess Specialist will work in a team environment that is aligned with the manufacturing value stream, and will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Substance material.
The BioProcess Specialist will:
o Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
o Own, investigate, write and approve associated deviations as well as support & coach Biotechnicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines.
o Ensure areas meet compliance standards and audit areas against standards – highlight any issues and work proactively with the area team and others to ensure resolution.
The BioProcess Specialist will have:
o Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience.
o Demonstrated experience working with NPI processes in production.
o Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
o Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
o Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
o Experience with regulatory inspections.
Please contact Kathy on 021 4777329 for full details on this role or apply directly through this advert.