Materials Management Supervisor

Louisville, KY, United States
Sep 13, 2020
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
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 2021. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

Position Summary:

The Materials Management Supervisor, to be based in Louisville, KY reports to the Manager, Supply Chain, is responsible for maintaining sufficient levels of materials for cell therapy manufacturing at Talaris Therapeutics. The Materials Management Supervisor will oversee GMP receiving, shipping, and kitting activities.

Principal Duties and Responsibilities:

The following is a summary of the significant functions of this individual's job. He/she may perform other duties, both major and minor, which are not mentioned below, and specific services may change from time to time.
  • Supervise materials management operations conducted within the Talaris facility in a manner that assures reproducibility and compliance with GxP regulation, including 21CFR Parts 11, 210, 211, 312, 600, and 1271
  • Provide necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews
  • Supervise the on-the-floor operations of GMP facility, including receiving, shipping, and kitting
  • Oversee cycle count process to ensure accuracy and control of inventory volumes
  • Responsible for maintaining inventory levels sufficient for cell therapy manufacturing
  • Manage disposition of GMP raw materials
  • Responsible for maintaining and accurate Bill of Materials (BOM)
  • Maintain materials management and warehouse areas in accordance with GxP requirements and company SOP's
  • Maintain procedures and documentation for material receipt, quarantine, release/reject and destruction
  • Maintain an up-to-date technical package for all GMP materials
  • Coordinates the daily activities with staff to ensure that all tasks are completed and compliant with applicable procedures
  • 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 materials management SOPs
  • Performs other duties as assigned

Minimum Education, Training, and Experience Required:
  • Bachelor's degree in supply chain or related discipline with 6+ years of relevant experience
  • 2 years of experience supervising staff
  • Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
  • Must be able to work on off-shift hours as well as part of the on-call rotation as needed
  • Previous experience supervising and leading materials management operations within a cGMP/cGTP compliant system
  • Strong leadership skills with the ability to train entry-level personnel, motivate staff members and develop a culture of operational excellence
  • Demonstrated ability to effectively manage personnel performance
  • Excellent time management and organizational skills with a demonstrated ability to meet deadlines

Additional Qualifications
  • Preparation of sterile media and aseptic technique is a plus
  • Ability to work effectively in a fast-paced, rapidly changing environment
  • Experience with electronic systems (ERP and QMS)
  • High-level presentation and writing skills
  • Willing to have a flexible schedule when needed
  • Self-motivated with a strong sense of ownership in responsibility

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k

Apply: Please submit resume or CV and cover letter to

Talaris is fully committed to equality of opportunity in all aspects of employment. It is the policy of Talaris to provide equal employment opportunity to all employees and applicants without regard to race, color, religion, national or ethnic origin, military status, veteran status, age, gender, gender identity or expression, sexual orientation, genetic information, physical or mental disability or any other protected status.