Material Operations Biotechnician (Temporary) - Ireland
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Company’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 company’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.
- This is a 23 month temporary position
- We are 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 organizational skills.
- Reporting to the Materials Operations Manager, the primary role of the Materials Operations Bio Technician will be the day to day operation of the warehouse, sampling and materials dispensary operations on-site.
- Coupled with this, the Materials Operations Bio Technician will also be responsible for preparing the on-site warehouse and any off-site storage for GMP operation as part of the Shanbally facility start up.
- This role requires flexibility with regards to work schedules and shift work may be required to support business needs.
- This role will operate within a team environment with an emphasis on safety and quality and will be committed to continuous improvement, teamwork, personal development and delivery of best in class service in support of Drug Substance manufacturing operations at the Shanbally facility.
- Demonstrate an active approach to safety, industrial hygiene, environmental, cold chain management and GMP/GDP compliance
- Receiving, inspection, labelling, booking and put away of all inbound inventory
- Sampling of GMP material as per approved sampling plans
- Dispensing, weighing and kitting of raw materials and consumables to support Manufacturing schedule on a day to day basis
- Manage Kanban system to support manufacturing operations
- Execute outbound shipments as per schedule including responsibility for all required documentation and scheduling of freight forwarders
- Oversee the environmental monitoring of both ambient and cold storage areas reporting and resolving any deviations through the relevant quality system
- Key user of Oracle ERP system, specifically materials management modules
- Manage inventory tracking program designed to maintain accurate inventory tracking (on-site & off-site), including cycle counting
- Implement corrective actions to ensure performance targets are consistently met and continuous improvement is demonstrated through KPI’s
- Oversee day to day interactions with vendor managed inventory provider on site
- Participate in regulatory inspections as SME in Materials Operations
- Working flexible shift patterns to meet business needs and Manufacturing schedule
- Relevant materials management/Quality certificate or diploma
- Relevant fork truck (counter balance, stacker) trained & licensed.
- DGSA license preferred
- IATA training preferred
- Manual Handling training
- Minimum 3 years experience working in GMP warehouse environment.
- Biopharmaceutical experience is desirable.
- Materials sampling, dispensing, weighing & kitting experience essential.
- Experience of GMP warehouse start up is preferable.
- Strong systems experience, Oracle preferably.
- Experience in product shipments and hazard material/waste handling is preferable.
- Forklift (counter balance and stacker) experience is preferable.
- Strong demonstrated ability in communicating and interacting across cross-functional teams.
- Demonstrated ability in implementing continuous improvement projects to deliver operational excellence.
- Experience with regulatory inspections.
Work closely with Quality Operations, Facility Services, Manufacturing and Supply Chain personnel to ensure efficient Materials Operations.
Interact with Materials Management group.
- 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.