Project Management Consultant

Clinical Supply Chain Consultant
July 24, 2019

To meet accelerating growth, DS Inpharmatics LLC (DSI) is seeking an experienced Project Manager to enhance our established team. LEARN MORE

Role and Responsibilities

In this position the project manager will support clients in a variety of ways:

  • Must be able to coordinate resources including, but not limited to, managing internal resources and expanding project scopes for the client where applicable.
  • Management of CMC groups (both internal and external), and directing CMC activities for multiple programs if required.
  • Establishing and managing vendors for drug substance manufacturing, drug product fill finish, knowledge of clinical packaging and distribution to meet client timelines is a plus.
  • Oversee and coordinate activities in support of authoring CMC sections for a variety of regulatory filings.
  • Using DSI or client specific systems to track and report on project progress and milestones.
  • Manage small teams of Subject Matter Experts with various skill sets to achieve clients’ objectives.
  • Track program budgets against a defined scope of work.
  • Must be able to manage more than one client and project at a time.

Qualifications and Education Requirements

  • Candidates must have a minimum of 10 years of practical experience in a CMC operations capacity with direct experience in the management of cross functional operations.
  • B.S. in the sciences

Prefered Skills

  • Familiarity with regulatory authoring projects
  • Experience with process optimization or validation
  • Drug development experience
  • Understanding of the basics of Supply Chain management
  • Understanding of CMO (vendor) selection and product transfer
  • Proficient in Microsoft Project, Excel, PowerPoint and Word is a plus

Location

    Remote/Virtual

Position Type

    Sub-Contractor

Travel Requirements

    Required Travel Up to 25% if directed by a client