Note: The job is a remote job and is open to candidates in USA. BioMarin Pharmaceutical Inc. is a leading global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. The GEO Operations Manager will manage day-to-day activities at Contract Manufacturing Organizations (CMOs), ensuring quality product delivery and operational readiness for new CMOs or processing steps.

Responsibilities

• 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 in collaboration with the procurement and EPM teams
• Represent assigned product, CMO and GEO Ops team at appropriate meetings, e.g. VPT, VST
• Establish and maintain GEO’s processes and project templates for ORP management
• Carry out Operations Gap Analysis of new CMOs and establish and lead subsequent mitigation plans
• Ensure smooth transition of Operations activities from PPQ/Launch Phase into the Commercial Process Team
• Lead site exit projects as required for GEO

Skills

• Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality
• BS/BA degree; life sciences, business, or supply chain management
• Will have an excellent understanding of the processes/unit operations
• 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
• Proven track records in effective decision making
• A high level of initiative, influencing, coaching as well as excellent organizational skills
• Experienced in working and managing in a regulated GXP environment
• Strong stakeholder and relationship management experience
• Excellent organizational, written and verbal communication, commercial acumen
• Experience in supply planning or inventory management
• Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired

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