Operations Manager, Global External Operations

Who We Are

Bio Marin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, Bio Marin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

As part of Bio Marin’s TOPS group, Global External Operation (GEO) has responsibility for managing all external manufacturing operations and performance at Contract Manufacturing Organizations (CMOs).

The GEO Operations Manager is responsible for managing day-to-day activities at one or more CMOs. Operations may include drug product operations (biologics and/or small molecules) and/or finished-goods packaging. Both clinical and commercial activities are in scope for each area, as required.

The role also supports operational readiness for new CMOs or new processing steps at an existing CMO. The successful candidate will partner with SMEs (both internally and with externally), as needed, to ensure quality product is delivered on time and in full.

• 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 overview of the GEO business.
• Coordinate as required Bio Marin 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 members of Bio Marin 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.

• BS/BA degree; life sciences, business, or supply chain management

• Will have an excellent understanding of the…