Bioprocess SpecialistLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
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.
Main areas of responsibility:
- Lead and implement continuous improvement initiatives that add value to MFG Operations
- Lead the execution of Drug Substance operational readiness plans for manufacturing campaigns for new and existing products
- Lead and support business process excellence implementation within Drug substance MFG (e.g. 5S, SMED, Leader Standard Work, PPM & Standard work)
- Initiate and lead productivity and value enhancement projects for Drug Substance MFG
- MFG Lead for CapEx projects and enterprise projects for Drug Substance MFG including development of LRP projects for Drug Substance MFG
- Manage CI governance process for Drug Substance MFG and CI project portfolio including implementation of MFG continuous improvements
- 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
- 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.
- 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.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- 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.
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
- Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
- Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours.
- 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.
- Supervise, and perform as needed, employee training in Manufacturing Support, Downstream and Cell Culture operations
- Effectively and consistently prioritize and delegate daily assignments and projects to the technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
- Strong process knowledge of drug substance manufacturing
- Excellent project management skills
- Proven ability to lead and deliver on multiple projects in parallel
- Agile and flexible to work on multiple initiatives
- Strong continuous improvement focus
- Demonstrated experience working with NPI processes in production.
- Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
- Strong collaboration skills
- Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections.
Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.