Clinical Supply Chain Manager (GMP) (#2768)

Job Description

We are seeking a highly motivated individual for the role of Clinical Supply Chain Manager to work in this exciting area of phage therapy. This individual will work closely with the external Vendors (for labeling, packaging, and distribution), cGMP, and cross functional areas i.e.; Clinical Operations team to ensure clarity of strategy and facilitate communication. In addition, the person is responsible for the management of clinical supply inventory.

Duties and Responsibilities

• Manage protocol-level drug product labeling and packaging activities for clinical trial material

• • In collaboration with other drug development functions, coordinate appropriate clinical trial materials quantities for stability testing requirements
  • Define, implement, and optimize the packaging schedules that integrate into the clinical trial plans, while keeping within the corporate budget
  • Participate in identifying CRO/CMOs and contract initiation
  • Responsible for providing clinical packaging forecasts to Supply Chain Management
  • Lead the effort of process definition, improvement and troubleshooting by appropriate use of resources and by influencing other departments
  • Guide logistics team member in distribution activities
  • Establish and foster relationships with internal cGMP manufacturing and packaging organizations
  • Responsible for training, developing and mentoring team members
  • Work effectively in a cross functional matrix environment, with internal and external customers
  • Maintain operations within contracted guidelines to assure the packaging of high-quality bulk and finished products
  • Support quality audits
  • Build and maintain a staff that is both technically qualified and well trained, while providing a motivating environment and opportunities for their professional advancement in a safety conscious environment
  • Develop, implement, and update all relevant SOPs, Batch Records and other documentation needed for cGMP compliance
  • Provide a safe working environment for employees
  • Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above
  • Other duties as assigned

Educational/Experience Requirements

• • • 5-8 years of directly related experience in Biotechnology Pharmaceuticals
    • 2 years management experience
    • Expertise in management of labeling, packaging, and distribution of a variety of drug product dosage forms
    • Supply chain management experience for drug manufacturing
    • Knowledge of the drug development process
    • Ability to work in a matrix environment
      • Excellent written and verbal communication skills
      • Strong communication and interpersonal abilities to influence the entire organization to run operations in an effective and lean manner
      • Bachelor’s degree in a scientific discipline is required.,