Materials Management Supervisor

Location
Louisville, KY, United States
Posted
Oct 12, 2020
Ref
668939544
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
Talaris Therapeutics, Inc. ("Talaris") is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. 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 2009 - 2016, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant, without rejecting their donated organ. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we 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

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

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

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.