GEO Operation Manager
BioMarin 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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind
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 individuals 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.
Global External Operations (GEO) Operations Manager - CORK
The GEO Operations Manager is responsible for the supply of product(s) from contract manufacturing organizations (CMO) by management of the business relationship and supply contracts. The position will be expected to engage with technical SME’s as required to ensure quality product is delivered as required.
- Execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product
- Manage the CMO meeting schedule in conjunction with your cross functional colleagues to ensure an engaging and collaborative environment.
- Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan.
- Manage escalations and communications within the process team/GEO site from an operations perspective.
- Collaborate with a cross functional team to ensure uninterrupted supply of product. This will involve both process team and non-process team colleagues.
- Perform root cause analysis, or equivalent, to understand issues and implement corrective actions as appropriate.
- Manage material movement between CMO sites with various internal partners.
- Attend at CMO to monitor production campaigns and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
- Manage and maintain with cross functional team a visual metric/dashboard to provide an oversight of the GEO business.
- Coordinate as required BioMarin activities in the evaluation of process changes, change requests and deviations to ensure timely resolution without impacting on supply.
- Act as the focus and conduit for communications between the CMO and with members of BioMarin manufacturing group and other departments to meet the supply plan.
- Lead and/or participate in technology transfers, new product launches, validation activities with the CMO and internal cross functional teams including Process Development, Regulatory Affairs and Quality departments
- Contribute to the development of formal systems and procedures for the selection of CMO
- Initiate and implement necessary control systems within budget and to reduce cost of goods
- With the Corporate Compliance and Quality departments, ensure that the CMO is compliant with cGMPs.
- Support contracts and negotiations with CMO.
- Support both the process team lead and operations specialist as required.
EXPERIENCE & Skills:
Minimum requirement of 3-5 years in Operations, Supply Chain or Quality.
BS/BA degree; life sciences, business, or supply chain management
Required skills needed to accomplish the responsibilities/essential functions include:
• Will have a strong understanding of the processes/unit operations assigned to the team.
• Demonstrated ability in leading/managing cross functional, multi-disciplinary teams.
• 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.
• Excellent people management, organizational, written and verbal communication, commercial acumen and negotiation skills.
• A high level of initiative, influencing, coaching and questioning skills are key role requirements, as well as excellent organizational skills.
• Experience in supply planning or inventory management.
• Experience in inventory reconciliation.
• Team leadership skills.
• Working knowledge of GXP regulations.