Associate Director / Director – Supply Chain Management
Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems through protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $313M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets, and we need your help to give patients and physicians better options to treat disease and advance cytokine science along the way.
Position Summary
We are seeking an Associate Director / Director of Supply Chain to support the Phase 2 / 3 product development of cytokine therapeutics. This highly visible role works closely with technical operations leadership and functional heads to provide supply chain and logistics expertise for the Synthekine Phase 2 and 3 clinical product development programs. The role reports to the Chief Technical Officer and is based in Menlo Park.
Responsibilities
Establish and manage procedures for the drug substance, drug product, and labeled / packaged product chain of custody and logistics.
Manage shipping and receiving of product samples and supplies from and between contract manufacturers.
Work with clinical operations to provide appropriate management of study supplies and product distribution.
Oversee GMP production inventory control, material management, and shipping / receiving operations.
Maintain US / EU sourcing, material supply, production capacity, logistics, and availability to meet forecast.
Collaborate with external partners to integrate timelines and deliverables with overall Synthekine project plans.
Provide oversight for the development and implementation of operations systems into the technical operations functions.
Manage supply‑chain budgets for logistics and distribution.
Ensure accurate and up‑to‑date records for state, federal, and insurance inspections.
Operate within compliance of FDA and ISO requirements and guidelines.
Partner with other departments as needed.
Position may require some travel.
Qualifications
BS degree with 8+ years (Associate Director) or 10+ years (Director) of experience in operations, supply chain management, and / or business systems.
Strong leadership and communication skills – both verbal and written.
Excellent business, financial, and negotiating skills, along with knowledge of quality systems, lean manufacturing processes, and project management.
Solid working knowledge of automated supply chain systems.
Knowledge of current requirements for GLP, cGMP, and GCP.
Experience with regulatory submissions.
Forward‑thinking, creative, and high ethical standards.
Team‑player with leadership skills and ability to influence others.
Well organized and self‑directed.
Strong interpersonal skills and ability to communicate with people at all levels of the organization.
Preferred Qualifications
Experience handling GMP DS, DP, and labeled / packaged product logistics to support clinical studies.
Strong supply‑chain background and prior experience with CMOs / CROs.
Expertise in using and / or developing clinical supply and inventory systems.
Prior experience setting up and / or supporting clinical study distribution systems and procedures.
Salary range for an Associate Director based in Menlo Park, CA is $180,000–200,000; for a Director it is $220,000–240,000. The final offer will depend on factors such as experience, industry, education, etc. Synthekine is a multi‑state employer, and this range may not reflect positions that work in other states. We comply with all state, federal and local laws regarding pay practices.
Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
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Supply Chain Associate • Menlo Park, California, United States