Clinical Supply Manager
Alkahest, Inc.
San Carlos, EEUU
hace 4 días

Description

Uniquely positioned to enhance quality of life in aging, at Alkahest, we are pioneering science that is rapidly being translated to the clinic.

Our approaches utilizein vivo, in vitro, proteomic, and molecular techniques to identify new therapeutics and apply them to patients.

We are seeking a Manager, Clinical Trial Supply with experience in the pharmaceutical or biotech industry. You will manage clinical supply chain oversight and logistics for both small molecule and biologics programs.

The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique clinical supply chain challenges present in a GMP environment.

PRIMARY RESPONSIBILITIES

  • Lead clinical supply function and manage overall project timelines to align clinical trial requirements with drug product availability, secondary packaging, labelling and supply distribution
  • Support clinical study teams with study drug demand, forecasting, and logistics planning
  • Lead and direct partnership with drug suppliers - manage relationships as well as forecasting and demand planning
  • Create the replenishment forecast for the contract manufacturer, review and / or aggregating demand to ensure all supply streams are represented
  • Track all supply inventories, allocate product lot, procure supply when necessary
  • Manage and negotiate contract manufacturer proposal / contract, obtain purchase orders with necessary approvals, perform monthly accrual with finance team and process invoices
  • Work with Quality Assurance for batch record review to ensure release of product domestically and internationally
  • Review and resolve all shipment issues (damage, temperature excursions, non-compliance). Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership
  • Provide expertise with packaging design / technologies
  • Creatively seek out ways to improve the supply chain process
  • Other duties may be assigned.
  • KNOWLEDGE AND EXPERIENCE

  • A Bachelor’s degree in business or biological sciences required, Supply Chain Management or related discipline preferred
  • Minimum of 5 years of planning experience in a combination of clinical supply chains in biotech / pharmaceutical industry
  • Working knowledge of cGMPs and pharma industry procedures and regulations
  • Theoretical and practical knowledge of clinical supply forecasting, demand planning and manufacturing capacity management
  • Knowledge / proficiency as a project manager, master production scheduler / planner
  • Ability to anticipate / define problems, collect and analyze data, draw valid conclusions and execute corrective actions and preventative measures
  • Global release and distribution logistics and cold chain experience is required
  • Must possess import / export expertise including customs, transportation, and regulatory guidelines
  • Strong interpersonal skills and the ability to work independently, as well as a member of a team
  • Must have exceptional verbal, written, presentation, communication and negotiation skills
  • Proficiency with : Microsoft Word / Excel / PowerPoint / Project software
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