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 though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M 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.
We are seeking a Director of Supply Chain and Business Operations to provide support for the development of cytokine therapeutics to treat cancer and autoimmune diseases. This individual will work closely with the Technical operations leadership team and functional heads towards achieving corporate & project goals by providing supply chain and logistics expertise for the Synthekine product pipeline.. This is a highly visible role that will interact with the full range of functions within our growing company. This position will report to the SVP Technical Operations and will be based in Menlo Park.
The Director of Supply Chain and Business Operations will be responsible for developing and implementing tactical and strategic plans for the supply chain management of Synthekine’s clinical products. This role will include the production scheduling and inventory planning, domestic and international shipping of drug substance and drug product, Cell therapy clinical sample and product logistics, 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 coordinates these efficiently with purchasing, production, development, research groups and others inside and outside the company.
Key responsibilities will include:
- Establish the procedures and manage the drug substance, drug product, and cell therapy chain of custody and logistics
- Manage various product and sample shipping and receiving from and between CMOs
- Work with Clinical operations to provide appropriate manage of study supplies and product distribution
- Manage the GMP production inventory control, material management, and shipping/receiving operations
- Establishes and oversees the strategy and plans for 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
- Identifies potential business and operational software and systems to help with efficiency and cost reduction
- 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.
- Provides leadership to organization, hiring and mentoring staff and to ensure all staff are adequately trained
- Partner with other departments
- Position may require some travel
- BS degree with 15+ plus years 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 MRP and ERP systems
- Experience implementing world class sourcing tools and operations business systems
- Knowledge of current requirements for GLP, cGMP, and GCP is also required
- Direct experience with regulatory submissions
- Forward-thinking and creative with high ethical standards
- Team player with leadership skills with ability to influence others to achieve successful regulatory filings and meetings.
- Well organized and self-directed
- Strong interpersonal skills with an ability to communicate to people at all levels of an organization
- Experience with handling GMP DS, DP, and Cell therapy products logistics to support clinical studies
- Strong Supply chain background and prior experience working with CMO/CRO experience a plus
- Expertise in using and/or developing MRP and ERP systems
- Prior experience setting up and/or supporting clinical study distribution systems and procedures
Please apply at firstname.lastname@example.org.
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an
inclusive environment for all employees.