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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