Clinical Supply Specialist – Contract

🕒 June 24

🇺🇸 United States – Remote

💵 $58 - $70 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 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