ASSOCIATE DIRECTOR/DIRECTOR OF SUPPLY CHAIN

Company: Syncopation Life Sciences, Inc.
Location: San Mateo
Posted on: June 24, 2022

Job Description:

At Syncopation Life Sciences, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples' lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.Syncopation is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, Syncopation has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.Join us to help make a difference.POSITION SUMMARYSyncopation is hiring a Associate Director/Director of Supply Chain skilled in cell orchestration, materials management, shipping logistics, packaging/labeling, and demand and supply planning. The candidate will work very closely across technical operations and clinical operations to address all aspects required to ensure readiness of our upcoming pivotal study for the lead autologous cell therapy asset. As the first supply chain hire into Syncopation, this individual will have an opportunity to come in on the ground floor and establish the necessary workflows for patient scheduling, chain of identify and ensuring that we meet our supply and turnaround time goals. We seek a highly motivated individual with the right experiences who presents with the combination of strategics thinking as well as hands-on skills needed to maintain velocity of the program in a fast-moving start-up company. The successful candidate will work closely with the Technical Operations team to support clinical supply chain for CAR-T cell therapy products. The individual will also collaborate cross-functionally to ensure timely infrastructure establishment and identification of tools to support efficiency and data management. The role will eventually report into technical operation's supply chain and manufacturing organization. Given the early stage of the company and this being the first role, there is strong potential for growth and scope expansion in this role as the company advances the product portfolio. The role is based in San Mateo, CA.WHAT YOU WILL DO AT SYNCOPATION

• Establish workflow necessary for patient scheduling, movement of incoming apheresis and outgoing engineered cell product
• Work with technical development, manufacturing, and clinical operations to ensure appropriate controls are in place in shipping and transportation of the incoming materials and product
• Manage a phase-appropriate supply and demand process to ensure manufacturing capacity is in place for the planned clinical manufacturing scope
• Define and implement necessary COI controls in the end-to-end process
• Establish workflows and processes with a line 0f sight to commercialization.
• Support bill of materials including procurement, logistics, and inventory/data management
• Manages the coordination, shipping, receiving, transfer, and logistics of raw materials, samples, product, and supplies.
• Work with cold chain management (chain of custody/chain of identity) vendors to establish clinical shipping logistics; report/resolve any shipment excursions, collaborating with Quality Assurance
• Work with raw material vendors and support supply agreements
• Establish packaging/labeling for drug products and any key raw materials, as needed
• Define and establish phase appropriate supply chain performance KPIs.
• Develop scheduling plans for manufacturing, apheresis/PBMC Receipts, and DP (Drug Product) shipments
• Engage with Clinical operations teams to manage receipt of incoming materials and initiate manufacturing activities
• Act as a technical operations point of contact to clinical scheduling and logistics team and external manufacturing to ensure clinical supply needs are met for each patient.
• Support identification and deployment of phase-appropriate supply chain systems and digital tools as the company portfolio evolves.THE RIGHT STUFF PREFERRED QUALIFICATIONS:
  • Bachelor's degree in engineering or life sciences with 10 plus year industry experience in a supply chain role, of which 3-5 years' experience should be directly relevant (example, cell therapy modality)
  • Demonstrated experience in establishing supply chain strategies and workflows for autologous or allogeneic cell therapies including, but not limited to, materials management, labeling for GMP (Good Manufacturing Practices) drug product, cold chain management, and demand and supply planning
  • Experience in working with multidisciplinary teams.
  • Strong problem-solving skills for developing creative, innovative solutions, and meeting project objectives are required
  • Highly organized and capable of leading/pursuing multiple projects independently
  • Experience with GMP requirements and interfacing with QA (Quality Assurance), clinical operations, external collaborators, outsourced testing laboratories highly desired.
  • motivated, excel at driving execution, detail oriented, creative approach to problem solving, and adept at working in a fast-paced environment
  • Must have interpersonal, organizational, written, and verbal communication skills, and the ability to work hands-on and collaboratively in a team environmentEEO & EMPLOYMENT ELIGIBILITYSyncopation Life Sciences, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Syncopation Life Sciences, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.Syncopation Life Sciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Syncopation, and it applies regardless of whether the position is located at a Syncopation site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Syncopation Life Sciences, Inc., San Mateo , ASSOCIATE DIRECTOR/DIRECTOR OF SUPPLY CHAIN, Professions , San Mateo, California