Associate Director/ Director, Supply Chain Management

Company Description:

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. Come join us and help us 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 provide support for the PH2/3 product development of cytokine therapeutics to treat cancer and autoimmune diseases. This individual will work closely with the technical operations leadership team and functional heads by providing supply chain and logistics expertise for the Synthekine Phase 2 and 3 clinical product development programs. This is a highly visible role that will interact with the full range of functions within the company. This position will report to the Chief Technical Officer and will be based in Menlo Park.

The Associate Director/Director of Supply Chain management will be responsible for administering the strategic plans for the supply chain management of Synthekine’s clinical products to support the ongoing clinical studies. This role will include inventory planning, domestic and international shipping of drug substance and drug product, DS/DP product logistics, labeling and packaging operations at CMO, internal shipping/receiving, operations systems support and procedure implementation. This role is also responsible for developing, implementing and maintaining supply chain and operations policies and procedures, developing material schedules, and coordinating these efficiently with purchasing,
production, development, research groups and others inside and outside the company.

Job Responsibilities:

• Establish the procedures and manage the drug substance, drug product, and labeled/packaged product chain of custody and logistics
• Manage various products and sample shipping and receiving from and between CMOs
• Work with Clinical operations to provide appropriate management of study supplies and product distribution
• Manage the GMP production inventory control, material management, and shipping/receiving operations
• Maintain the US/EU sourcing, material supply, production capacity, logistics, and availability to meet forecast.
• Collaborate with our external partners to integrate timelines and deliverables with the overall Synthekine project plans
• Provides oversight for the development and implementation of the operations systems into the technical operations functions.
• Manages Supply chain budgets for logistics and distribution
• Ensures that all records for state, federal, and insurance inspections are accurate and up to date.
• Operates within compliance with FDA and ISO requirements and guidelines.
• Partner with other departments
• Position may require some travel

Qualifications:

• BS degree with 8 years (Associate Director); 10 years (Director) in Operations, supply chain management, and/or business systems experience
• Strong leadership, communication (both verbal and written) skills
• Excellent business, financial and negotiating skills are required along with knowledge of quality systems, lean manufacturing processes and project management knowledge
• Strong working knowledge of automated supply chain systems
• Knowledge of current requirements for GLP, cGMP, and GCP is also required
• Experience with regulatory submissions
• Forward-thinking and creative with high ethical standards
• Team player with leadership skills with ability to influence others
• Well organized and self-directed
• Strong interpersonal skills with an ability to communicate with people at all levels of an organization

Preferred Qualifications:

• Experience with handling GMP DS, DP, and labeled/packaged product logistics to support clinical studies
• Strong Supply chain background and prior experience working with CMO/CRO is a plus
• Expertise in using and/or developing clinical supply and inventory systems
• Prior experience setting up and/or supporting clinical study distribution systems and procedures

The anticipated salary range for the position of Associate Director based in our Menlo Park, CA office is $180,000-200,000; The anticipated salary range for the position of Director is $220,000-240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state, federal and local laws regarding pay practices.

Please apply at careers@synthekine.com.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).