Operations Readiness Planning Manager / Ops Manager - Global External Operations

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Job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.

As part of BioMarin's TOPS group, Global External Operation (GEO) has responsibility for managing all external manufacturing operations and performance at Contract Manufacturing Organizations (CMOs).The GEO Ops manager / Operations Readiness Planning (ORP) Lead will have responsibility for the operational readiness for a new CMO and/or 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.Key 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.

Additional ORP focused responsibilities, (as required):

• 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.

EXPERIENCE & Skills:Minimum requirement of 5 years leadership experience 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 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.
• Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
• Excellent organizational, written and verbal communication, commercial acumen.
• Experience in supply planning or inventory management.

Role is based in Novato, CA and hybrid workstyle. BioMarin defines hybrid as 2-4 days onsite in Novato. In addition to onsite days, 20% travel required both domestically and internationally in Asia.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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