Description
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.
Job Specification – QC Microbiology Manager
Location: Cork
Department: Quality Control (QC)
Industry: Biopharmaceutical
4 days onsite minimum
Role Overview
The QC Microbiology Manager reports to the Head of QC and is responsible for leading the QC Microbiology laboratory team at the Shanbally site. The team delivers the microbiological testing that underpins release and monitoring of drug substance and drug product, including anaerobic bioburden, environmental monitoring, water sampling, plate reading, growth promotion and associated trending and reporting.
It is expected that the incumbent will lead in a high-performing, team-based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, alongside strong organisational and planning skills.
The incumbent must possess technical expertise in microbiology and aseptic operations, and demonstrate both technical and personnel leadership. The role provides co-ordination and alignment between QC, QA, Manufacturing, Facilities and Supply Chain so that microbiological testing and monitoring commitments are delivered in line with the site supply plan and quality capacity.
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.
- ✓Plan resource and capacity for the microbiology team against the manufacturing schedule, and manage stock of media, consumables and reference cultures.
- ✓Maintain the laboratory in an inspection-ready state and represent QC Microbiology during regulatory inspections, customer audits and internal audits.
- ✓Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
- ✓Interface with other BioMarin departments (Quality Assurance, Manufacturing, Facilities, Regulatory Affairs, Supply Chain) and with external contractors and contract laboratories as necessary.
- ✓Participate as required in global project teams relating to QC Microbiology, contamination control strategy and wider quality activities.
- ✓Support budget preparation and monitoring, including capital equipment needs, facility needs, staffing needs and contract service requirements.
- ✓Identify and conduct personnel training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.
- ✓As required, act as designee for the Director, QC in their absence.
- ✓Other duties as assigned.
Required Experience & Skills
- ✓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.
- ✓Knowledge and experience of lean laboratory principles and continuous improvement is preferable.
- ✓Excellent written and verbal communication skills, with a customer focus and ownership of the speed, quality and accuracy of delivery.
- ✓Self-motivated, adaptable and able to work under pressure in a growing, multi-product environment.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.