We are hiring for a Clinical Supply Chain Associate with 2-5 years of clinical supplies experience. You will have an opportunity to join a growing organization in the biopharmaceutical industry!
Responsibilities:
Coordinate the day-to-day clinical supply activities across active studies under the direction of the Clinical Supplies Leads
Maintain accurate, lot- and kit-level traceability records for investigational and auxiliary materials
Maintain and review study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout
Track vendor deliverables and shipment status, escalating delays or issues to the Clinical Supply Chain Lead
Assist in monitoring temperature-controlled shipments and support investigation of excursions or deviations under guidance.
Maintain vendor contact lists, shipping schedules and standard operating procedures
Support day-to-day monitoring of the IRT/RTSM system, including kit inventory status and resupply alerts
Monitor retest and expiry dating of drug supplies and comparators,, including collaborating with CMC for stability data updates and overseeing relabeling activities at depots and sites as needed
Coordinate deliveries from depots to clinical sites to ensure on time and in full delivery of clinical materials
Ensure all required shipment documentation, Proof of Delivery (POD) documentation forms, and study specific records are complete, accurate, available to the appropriate parties and filed appropriately
Archive documentation in Trial Master Files as required
Track and help resolve temperature excursions.
Qualifications:
Bachelor's degree in Supply Chain, Shipping/Logistics or related field.
2-5 years of experience in clinical supplies or logistics in the pharmaceutical/biotechnology or medical device industry
Exceptional attention to detail, ability to effectively communicate with others, good customer service skills and ability to think critically and solve problems quickly and accurately
Ideal candidate is organized, has excellent communication skills, sense of urgency and is able to adapt to a rapidly changing environment
Import/Export experience is required
Ability to understand timelines and when each tasks need to be done
Experience in cGMP/GDP and regulatory regulated environment (Pharma, combination product, Biotech, Med device, solutions, solid dosage, semi-solids dosage form, etc.)
Oracle NetSuite or other ERP supply demand management tools
Experience with both development, clinical and commercial supplies a plus.
Additional Details:
If you live local to Orange County, you have the option to work out of our beautiful Irvine office, complete with onsite gym, pool, table tennis, snacks and drinks, and occasional catered meals. We provide fully remote or hybrid work options.
This position reports directly to our Clinical Supplies Leads.
Some travel may be required - up to 15%
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.
