Logistics Specialist – Supply Chain

Talaris Therapeutics, Inc. (“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients. We also expect to initiate two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

Job Description

The Logistics Specialist is responsible for the coordination and planning of the vein-to-vein process at Talaris Therapeutics. The Logistics Specialist is responsible for the day-to-day interface activities with Talaris Clinical Operations and Talaris Chemistry, Manufacturing and Controls (CMC) groups and the clinical sites.

Primary Responsibilities

  • Lead routine production planning meetings and provide timely updates on clinical site availability and product transfers to Talaris Clinical Operations and Talaris Chemistry, Manufacturing and Controls (CMC) groups
  • Responsible for timely product release and on-time shipments of Drug Product (DP) to clinical study sites
  • Coordinate Starting Material, Drug Substance (DS) and Drug Product (DP) shipments
  • Responsible for developing and maintaining courier and clinical site relationships
  • Responsible for daily monitoring, input, and coordination of vein-to-vein logistics systems
  • Collaborate with internal and external parties to establish and maintain consistent, timely and accurate reporting of clinical material using the vein-to-vein platform
  • Resolve shipping and logistics delays and other challenges
  • Provide support to the planning and scheduling of products and starting materials
  • Works closely with couriers to ensure that shipments are processed in a manner that is compliant with global customs regulations, including but not limited to the proper coding of clinical material, generation of customs documents, and application for import and export permits, as necessary
  • Coordinate with stakeholders on distribution process and system improvements, working within Supply Chain as well as cross functionally with peers to proactively implement process improvements to reduce risk and costs and allow for an efficient and robust supply-chain
  • Participate in the identification of industry trends and best practices
  • Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and functions
  • Responsible for completing deviations, performing investigations, CAPA implementation and continuous improvement of logistics SOPs
  • Fully proficient on applicable SOP’s and demonstrate ability to perform responsibilities with minimal supervision

Minimum Requirements

  • Bachelor’s Degree or 5+ years in a related supply chain/planning/coordinating/manufacturing role
  • Prior experience in a GxP environment; specifically, within the supply chain
  • Experience managing complex schedules and priorities in dynamic environments

Additional Qualifications

  • Ability to work effectively in a fast-paced, rapidly changing environment
  • Ability to multitask on a daily basis and maintain multiple projects in parallel
  • Excellent people skills, with demonstrated ability to communicate effectively across functional groups and manage relationships
  • High level presentation and writing skills, with experience presenting to functional teams
  • Excellent time management and organizational skills, demonstrated ability to manage multiple projects and meet deadlines
  • Experience with electronic systems (ERP and QMS)

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is an equal opportunity employer and prohibits unlawful discrimination.