Clinical Supply Manager

Location
San Carlos, California
Posted
Jun 07, 2021
Required Education
Bachelors Degree
Position Type
Full time

Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease.

We are seeking a Manager, Clinical Trial Supply with experience in the pharmaceutical or biotech industry. You will manage the clinical supply chain and logistics for both small molecule and biologics programs. The candidate is responsible for planning, forecasting and distribution of Investigational Product (IP) supply for multiple clinical trials.  Activities are performed on time, within budget, and with good quality, in compliance with Regulatory Authorities' regulations/guidelines and Alkahest’s SOPs. 

PRIMARY RESPONSIBILITIES

  • Lead clinical supply function and manage overall project timelines to align clinical trial requirements with IP availability
  • Oversee primary/secondary packaging, labelling and supply distribution performed by Contract Maintenance Organizations (CMOs)   

·       Manage and maintain a positive relationship with CMOs  

·       Create the replenishment forecast, 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 CMO proposals/contracts, obtain purchase orders with necessary approvals, perform monthly accruals with finance team, and process invoices
  • Work with Quality Assurance for batch record review to ensure release of product domestically and internationally
  • Review return and destruction records; communicate with CROs and CMOs to resolve issues. Perform drug accountability from bulk drug, production, distribution, and returns/destruction, and authorize final destruction
  • Review and resolve all shipping 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

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