Operations Manager, Global External Operations
About The Position
BioMarin is a global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. The Technical Operations (TOPS) group is responsible for creating drugs for clinical trials and scaling production for the commercial market. Within TOPS, the Global External Operation (GEO) team manages all external manufacturing operations and performance at Contract Manufacturing Organizations (CMOs). The GEO Operations Manager is responsible for the day-to-day activities at one or more CMOs, including drug substance operations (biologics and/or small molecules) for both clinical and commercial activities. This role also supports operational readiness for new CMOs or new processing steps at existing CMOs, partnering with internal and external Subject Matter Experts (SMEs) to ensure quality product is delivered on time and in full.
Requirements
- Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality.
- BS/BA degree; life sciences, business, or supply chain management.
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
