Head of Supply Chain

1 month ago

Cambridge, United States Alkeus Pharmaceuticals, Inc. Full time

About Alkeus Pharmaceuticals:

Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.


Position Summary

The Head of Supply Chain is accountable for developing an end-to-end supply chain organization to ensure efficient delivery from manufacturing through distribution. The incumbent is responsible for developing and managing end-to-end supply chain processes, including Sales & Operations Planning, Logistics & Trade Compliance, Artwork/Labeling and Secondary Packaging, Serialization, and Distribution. This role is critical in the development and seamless execution of launch strategies and plans that drive commercial market readiness.Oversee all supply aspects of commercial launch readiness for Gildeuretinol (ALK-001) by collaborating across the organization with Commercial, Finance, Market Access/Trade, CMC, Quality and Regulatory



Primary Responsibilities

  • Build capabilities in all key areas of Supply Chain – Plan/Source/Make/Deliver, including cold chain logistics, import/export compliance, and serialization
  • Develop a Sales & Operations Planning process to ensure consensus and alignment between Supply Chain, Finance and Commercial on business objectives and supply plans
  • Develop robust supply plan from raw material to drug substance to bulk drug product manufacturing and secondary packaging activities
  • Conduct scenario plans to determine optimal supply strategy
  • Ensure product readiness, partnering closely with external suppliers to address challenges and manage performance through thoughtful KPIs
  • Collaborate with Procurement/Strategic Sourcing in negotiation of applicable contracts and develop supplier strategy; identify, evaluate, select and manage external partners
  • Oversee risk management, proactively identifying risks and developing mitigation plans to prevent supply disruption
  • Lead with a continuous improvement mindset to build a reliable and efficient supply chain organization
  • Support CMC activities including regulatory submissions, inspections, and queries


Qualifications:

  • Advanced degree with a minimum of 10 years of industry experience in a highly regulated pharma/biotech supply chain position
  • Experienced in transitioning from clinical stage to commercial launch is highly preferred
  • Experienced in design and implementation of electronic inventory systems, global serialization experience (EPCIS, Tracelink)
  • Experience working with GMP manufacturing sites in China strongly preferred


Skills and Key Success Factors

  • Entrepreneurship spirit with a passion to build, learn and evolve with the team.
  • Highly organized and detail oriented with a passion to deliver quality results.
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values, and ethical standards
  • Ability and aptitude to manage ambiguity and adaptability to change
  • Emphasize the need for self-motivation and the ability to work independently


Other Relevant Information

  • Travel: Up to 10%


Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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