LSC are resourcing BioProcess specialists to work in a high-performing, team based biotech manufacturing organization based in Cork. Reporting to the New Product Introduction Associate Director, the primary role of the NPI Bioprocess Specialist is to support product launch activities.
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.
o Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
o Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
o Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
o Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems.
o Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours.
o Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
o Supervise, and perform as needed, employee training in Manufacturing Support, Downstream and Cell Culture operations
EDUCATION and EXPERIENCE
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 James on 021 4777329 for full details on this role or apply directly through this advert.