Specialist, Supply Chain OperationsLocation United Kingdom Workstyle Hybrid 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.
Specialist, Supply Chain Operations - Closing date Tuesday 5th September
The GEO Supply Chain Operations Specialist serves as an integral member of the Global External Operations team who has responsibility for and plays a key role in readiness for external contract manufacturing activities relating to commercial drug products. They help coordinate starting material, drug product and finished packaged goods supply needs between contract manufacturers and internal BioMarin teams to ensure that all commercial and clinical needs are defined and met. The candidate is required to work closely with a cross-functional team and coordinate activities between Supply Chain, Operations, Quality, MSAT and the contract manufacturer. The GEO Supply Chain Operations Specialist reports to the Director, Supply Chain Operations, GEO
- Analyse, issue, and execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product.
- Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan.
- Maintain a visual metric/dashboard to provide oversight of the production plan.
- Act as the focus and conduit for communications between the CMO and with members of BioMarin Process Teams and other departments to meet the supply plan.
- Attend periodically at the CMO to monitor production and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
- Manage ERP aspects at BioMarin for purchasing and production efforts at CMO.
- Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at the CMO site.
- Coordinate BioMarin activities in the evaluation/execution of issues, process changes, change requests and deviations to ensure timely resolution without impacting on supply.
- PO and Invoice Management – generation and coordination of POs and resolution of payment holds.
- Commit Process – maintain work order dates to match CMO order confirmations and changes in schedule to support supply plan visibility and master scheduling.
- Shipment Management – form completion, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples
- Inventory Reconciliation – manage monthly reconciliation process for relevant CMOs, prepare for and be primary SME/point of contact for inventory audits.
- Coordination of reference standard supply with relevant CMOs
- Coordination of annual stability samples with relevant CMOs
- Other duties as assigned.
EDUCATION AND EXPERIENCE
- Minimum requirement of 3-5 years in Operations, Supply Chain or Quality.
- BS/BA degree; life sciences, business, or supply chain management
- Will have a good understanding of the processes/unit operations assigned to the team.
- Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
- Strong written and verbal communication, commercial acumen.
- A high level of initiative and questioning skills are key role requirements, as well as strong organizational skills.
- Experience in supply planning or inventory management.
- Experience in inventory reconciliation.
- Working knowledge of GXP regulations.
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.