Clinical Supply Chain Associate/ Associate 2Location Novato, California
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.
This position is responsible for supporting the on-time delivery of clinical supplies and ancillaries across all Biomarin clinical trials. This role will be responsible for supporting the Clinical Supply Chain Product Leads by contributing to various work streams with key service providers/stakeholders and supporting other projects as required.
- Supports the CSC Product Lead(s) in executing all operational and logistical duties for on-going clinical trials. Executes clinical supply project plan. More experienced candidate may lead these activities.
- Monitors shipment status of drug supplies to clinical sites
- Manages ancillary supplies for all programs
- Executes temperature excursion process
- Supports distribution activities with the distribution vendor, including maintenance of shipping forecasts, generation of drug orders, review of shipping documentation and obtaining approval to ship
- Participates in clinical supply meetings
- Performs study close out activities and maintains/archives CSC-related documents for Trial Master Files (TMF)
- Coordinates destruction and performs reconciliation of investigational drug at depot level
- Monitors depot storage capacity/utilization reports and manages aging inventory
- Assist CSC Product Lead(s) with vendor contracts and monitoring PO status
- Supports other department initiatives and administrative duties as needed
Minimum requirement of 1-3 years in supply chain field.
Required skills needed to accomplish the responsibilities/essential functions include:
- Experience in supply planning or inventory management
- Experience in inventory reconciliation
- Investigations skills
- Oral and written communication skills
- Organizational skills
- Working knowledge of GCP/GDP regulations
Desired skills to accomplish the responsibilities/essential functions include:
- IXRS experience
- Team leadership skills
- Cold chain logistics knowledge
- Skilled at complex problem solving
- Skilled at influence and negotiation
- Presentation skills
- Other desired competencies include:
- Self-motivated and takes responsibility for performance
- Pursues objectives persistently despite obstacles and setbacks
- Ability to adapt in a changing environment
- Ability to discern the feelings behind the needs and wants of others
- Exhibits curiosity and passion for growth/learning
- BS/BA degree; life sciences, business, or supply chain management
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.