Associate 2, Clinical Supply Chain
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients' lives.
SUMMARY Work independently with minimal supervision performing end-to-end clinical supply chain management activities. Partner with other BioMarin clinical team members to ensure clinical trials are appropriately supplied with product; ensure inventory levels are maintained at depots and sites. Provide study information/ updates and technical supply chain expertise to support various processes such as demand/ supply planning, IXRS development, implementation and management, and inventory management including allocation and distribution. Analyze clinical supply chain processes and associated processes, and contribute to improvement efforts. RESPONSIBILITIES Supply Clinical Supplies including: IMP Placebo Comparator
Manage inventory levels and distribution of Clinical Supplies: Ensure country/site specific inventory levels are consistently maintained throughout the distribution network. Provide shipping forecast for budgeting and planning purposes Provide shipping requirements (e.g. temperature sensitive, temp monitor, pre-qualified shipper, ambient shipper, etc.) and review/approve distribution protocol Facilitate the retrieval of Import Permits if required; working with Logistics, Regulatory Affairs, CLO and CRO Ensure Regulatory “green light” as well as “technical green light” (i.e. QA/ QP release) is in place prior to initial and re-supply shipments to clinical sites Track shipment (i.e. status) of clinical supplies Process manual ship requests for non-IXRS studies
Manage Temperature Excursions Determine status of supplies as a result of excursions during shipments as well as on site excursions Escalate excursions to QA as needed Supporting investigations due to temp excursions Provide training to designees
Clinical study team member Participate in regular study meetings Track appropriate approvals (i.e. EC, RA, protocol amendments, expiry dating, country specific labels) and communicate progress to various team members such as CMO and QA.
IXRS team member Participate in evaluation of IXRS vendors Participate in URS review/ approval and UAT Manage clinical supply inventory/ re-supply strategy in IXRS Participate in regular IXRS team meetings
Review protocol, provide feedback, share info with Clinical Planning team; ensure Planning team is kept updated on any study changes that may affect IMP requirements Provide guidance for returns for destruction (i.e. ensure site can provide Cert of Destruction, or provide return to depot information) Perform Final IP reconciliation Contribute to the Pharmacy Manual Participate in Investigator Meetings EXPERIENCE Minimum 5 years experience in the clinical supply chain or related field required Inventory management experience required, 3 years minimum Working knowledge of current GMP/GCP regulations required IXRS experience desired Distribution experience, including Cold Chain required Experience in biopharmaceutical manufacturing preferred. Demonstrated proficiency with Microsoft Excel and good working knowledge of other MS Office applications. Demonstrated ability to manage multiple projects and priorities, and have strong data analysis, problem solving, and decision-making ability Demonstrated ability to work with all organizational levels and work effectively in a team environment, demonstrate strong verbal and written communication skills Demonstrated examples of a high level of personal initiative and ability to function autonomously with a strong sense of urgency, self-confidence, and comfort with new and rapidly changing situations and environments Experience with ERP systems highly desirable; Oracle R12 Business Suite preferred EDUCATION Bachelors in Operations/Supply Chain Management, Engineering, or related Business field with 5 - 8 years experience in the supply chain field. APICS certification and or supply chain education preferred. Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. ~BIO