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Clinical Supply Lead

Workforce Genetics

Clinical Supply Lead

Gaithersburg, MD
Paid
  • Responsibilities

    Built on the foundation of trust, transparency, and a shared desire to create a drug development company that operates without barriers, our client is able to bring critical new medicines to market faster. The only way to do this is to hire the best independent thinkers and collaborators, provide them with better access to the science, and then give them the freedom to achieve outstanding results.

    Our client is currently looking to hire a Clinical Supply Lead that will oversee and manage supply chain activities for multiple studies supplied globally. In this role, you will work as part of a cross functional team to develop and execute supply strategy with internal and external customers.

    RESPONSIBILITIES:

    • Oversees all aspects of clinical supply planning, capacity planning, labeling/packaging production strategy and execution, and risk management for clinical products

    • Oversees and actively manages relationships with labeling/packaging/distribution Contract Manufacturing Organizations to ensure production and inventory targets are communicated and met

    • Assist with study costing and contract requests and is accountable for financial tracking and reconciliation of projects.

    • Collaborates with CMC Team Leaders to ensure Drug Substance and Drug Product availability and provides forecast data for inventory maintenance

    • Provides input and data for regulatory filings

    • Actively communicates, collaborates with and contributes to other functional areas including Clinical Operations, Quality Assurance, CMC, and external partners and drives to achieve the best development and business results for the company

    • Participates in the Supply Chain team and supports Commercial Supply Chain activities, as required

    REQUIREMENTS:

    • Bachelor’s degree in a technical or scientific discipline

    • 4+ years of relevant supply chain experience in the bio-pharmaceutical industry including supply planning, CMO oversight, and labeling and packaging

    • Experience in Clinical Manufacturing Operations and/or Quality

    • Broad experience in GMP operations and a proven track record of successfully leading and contributing to cross-functional teams

    • Strong communication, interpersonal/team skills, and demonstrated strategic planning capabilities

    • Ability to prioritize and manage multiple tasks simultaneously, to identify and resolve issues, and effectively manage timelines