Sterile Manufacturing Technician

Overview

Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.

We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

Bio Marin’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 Bio Marin’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.

Onsite Role - Shanbally, Cork

3 Shift Rotation

The Sterile Manufacturing Technician will support commercial manufacturing for drug product manufacturing as well as product transfers and operational readiness activities of new products. This facility contains a state-of-the-art flexible line using isolator technology for filling of vials and syringes and the facility supports both clinical and commercial filling for the majority of the Bio Marin biologics product portfolio.

Role

Summary:

Bio Marin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. The Sterile Manufacturing Technician will perform recombination and pooling of drug substance; filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities.

This role will also have responsibility for operation of the parts washer and autoclave. Responsibilities also include root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and/or corrective actions. The ideal candidate will be able to demonstrate a proven track record in a quality-focused, operational GMP environment where attention to detail and commitment to the task at hand is key.

Previous GMP Sterile Filling experience is required with a strong preference for candidates with isolator vial and syringe filling experience. Previous experience in a leadership role or senior technician role is preferred.

Responsibilities: Reporting to the Drug Product Team Lead, the successful candidate shall work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility. The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others.

This role requires flexibility with regards to work schedules. This role is currently a 3-Shift rotation with potential for future shift work changes as required:

• Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment.
• Perform all operational tasks…