Procurement Specialist

JobTitle:             Procurement Specialist
Schedule:            Full-time ( Shift Work)
Location:            Louisville, KY
Reports to:         Manager, Supply Chain
Direct Reports:  N/A

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

Principal Duties and Responsibilities:

  • Procure materials for clinical manufacturing operations in compliance with Talaris policies and procedures as well as GxP and financial regulations, including 21CFR Parts 11, 210, 211, 312, 600, 1271 and the Sarbanes-Oxley Act
  • Generate purchase orders for GxP materials with input from functional representatives
  • Negotiate supplier agreements for GxP activities
  • Manage Talaris’ approved supplier list
  • Maintain an accurate Bill of Materials
  • Leads distributer operational assessments and due diligence including financial evaluations and business continuity evaluations
  • Notify suppliers of quality issues with materials or services and for requesting appropriate corrective actions are taken to prevent recurrence
  • Establish and manage a supplier change notification system within Talaris
  • Analyze invoices and receipt documentation for accuracy and completeness of goods delivered
  • Assist with completion of NDAs and CDAs
  • Maintain procedures and documentation for material procurement
  • 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 SOPs

Secondary Responsibilities:

  • Perform additional job-related duties as required
  • Support Talaris finance department in financial audit

Minimum Education, Training, and Experience Required:

  • Bachelor’s degree in business, supply chain or related discipline with 6+ years of relevant experience
  • Knowledgeable of the Current Good Manufacturing Practices (cGMP’s) and Sarbanes-Oxley Act
  • Previous experience in procurement activities within a cGMP/cGTP compliant system
  • Excellent written and verbal communication skills
  • Ability to build and maintain relationships and rapport
  • Demonstrated knowledge of contract negotiations
  • Excellent time management and organizational skills with a demonstrated ability to meet deadlines
  • Ability to travel and meet suppliers as necessary

Additional Qualifications

  • Ability to work effectively in a fast-paced, rapidly changing environment
  • Experience with both paper-based and electronic systems
  • High level presentation and writing skills
  • Willing to have a flexible schedule when needed
  • Self-motivated with a strong sense of ownership in area of 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.