GEO Supply Chain Operations Associate

Job description

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. 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. The GEO Supply Chain Operations Associate will serve as an integral member of the Global External Supply Chain Operations team who have responsibility for and play a key role in supporting external Contract Manufacturing Operation (CMO) activities relating to Clinical drug products. They will help coordinate starting material and drug product and finished packaged goods supply needs between CMOs and internal BioMarin teams to ensure that all product supply needs are defined and met. The candidate will be required to work closely with a cross-functional team and coordinate activities between Supply Chain, Quality, MSAT and the CMO. The GEO Supply Chain Operations Associate will work with the Process Team Owner, GEO. KEY RESPONSIBILITIES • Manage ERP aspects at BioMarin for production efforts at CMO & Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at CMO site. • PO and Invoice Management – generation, and coordination of POs • Shipment Management – Form completion, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples • Inventory Reconciliation – manage monthly reconciliation process for relevant CMOs, prepare for and be primary SME/point of contact for inventory audits • Coordination of reference standard supply with the relevant CMOs • Coordination of annual stability samples with Novato and the relevant CMOs. • Accountable and responsible for maintaining accuracy of Tier 2 Master Data (planning and GMP production recipes, quality parameters, dispensing and sourcing rules, planning attributes, formulas, and routings) for Planning and GMP Production Recipes and Formulas (Not process instructions). EXPERIENCE Minimum requirement of 3-5 years 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 a good understanding of the processes/unit operations assigned to the team. • Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals. • Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired. • Strong written and verbal communication, commercial acumen. • A high level of initiative and questioning skills are key role requirements, as well as strong organizational skills. • Experience in supply planning or inventory management. • Experience in inventory reconciliation. • Working knowledge of GXP regulations. Desired Skills: Desired skills to accomplish the responsibilities/essential functions include: • Clinical Packaging Operations/Supply Chain • Cold chain logistics knowledge 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.