Clinical Supply Specialist – Contract

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $58 - $70 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

📋 Description

• Supports the development and execution of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and ancillaries. • Coordinate and track bulk drug orders to ensure adherence to pre-defined supply and resupply timelines. • Monitor site inventory on a daily basis; coordinate and track drug shipments to ensure uninterrupted supply. • Supports drug product inventory management and distribution in partnership with 4DMT’s clinical partners; evaluates drug utilization versus forecast considering country requirements and logistical timeline. • Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout. • Tracks and resolves study and depot level temperature excursions. Provide routine reporting of drug wastage due to these excursions. • Archives Proof of Delivery (POD) documentation. • Maintain traceable documentation to support GXP activities. • Archives documentation on Trial Master Files as required.

🎯 Requirements

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent). • A minimum of 3 years in the pharmaceutical industry or relevant work experience. • A minimum of 1 year in Clinical Supply Chain. • Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products. • Experienced with Interactive Response Technology - IRT systems for inventory management and resupply. • Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities; working knowledge of GMP/GCP/GLP regulations.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities