Clinical Supply Manager

San Diego, CA

  • Samumed is looking for a highly motivated Clinical Supply Manager to join its Chemistry, Manufacturing, and Controls team, based in Samumed’s San Diego office.
  • The Clinical Supply Manager is responsible for interfacing between Clinical Operations and Manufacturing groups to ensure timely availability of Investigational Product and for forecasting demand and allocations for drug substance/drug product, components and ancillaries to meet clinical/development demand.

Specific Responsibilities

  • Interface between Clinical Operations and Manufacturing groups to ensure timely availability of Investigational Product.
  • Forecast demand and allocations for drug substance/drug product, components and ancillaries to meet clinical/development demand
  • Aligns with Clinical Development, Clinical Operations, QA, and Clinical Data Management to help develop an inventory strategy per program, study and region.
  • Qualifies vendors for clinical packaging. 
  • Oversees vendor processes to create packaging designs, serializations, storage requirements, and logistics plans for clinical trials.
  • Reviews and approves manufacturing documents, such as batch records, COAs, specifications, and stability programs/release data.
  • Drives label creation and approvals process, including translations for all countries.
  • Manages IP shipments, storage, returns, reconciliation, and destruction activities.
  • Reviews IP temperature excursions, quarantines, and erroneous IP handling.
  • Monitors inventory levels, drug product expirations, and re-supplies.
  • Supports stability testing and studies to maintain drug product integrity.
  • Works with vendors to generate inventory reports.
  • Reviews department budgets and spending for relevant clinical trials and related activities.
  • Invoice processing and approvals.
  • Supports regulatory filings including IND submission information, and audits from all health agencies.
  • Provides support in the set-up and design of Medidata Rave RTSM and utilizes system for IP supply monitoring and distribution.
  • Functional in Quality Management software, Q-Pulse.
  • Assists in manufacturing and laboratory audits where applicable.
  • Manage/negotiate/renew contracts with third party manufacturing/packaging sites, in collaboration with legal and technical teams
  • Manage/negotiate/renew contracts with third party manufacturing/packaging sites, in collaboration with legal and technical teams
  • Initiate commercial supply planning activities when appropriate

Requirements

  • Bachelor of Science Degree


Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.