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Supervisor, Manufacturing Operations

Company: Talaris Therapeutics
Location: Louisville
Posted on: January 17, 2020

Job Description:

Unique opportunity to join an exciting, mid-stage biotechnology company 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 Supervisor, Manufacturing Operations provides direct leadership and support to a team of production professionals conducting clinical cell therapy manufacturing in a GMP and GTP compliant ISO 7 classified cleanroom facility. The Supervisor, Manufacturing Operations is responsible for the day-to-day manufacturing operations, and ensures the safety and quality of the cell product. Primary responsibilities:

  • Supervise manufacturing 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.
  • Train, supervise, and mentor GMP production personnel to develop a strong team of highly skilled professionals responsible for conducting aseptic processing operations.
  • Coordinate manufacturing schedules with Supply Chain, Quality Assurance, Quality Control, and Facilities' teams to assure timely manufacturing, and batch record review and product release.
  • Responsible for identifying technical training needs and design, implement and deploy an effective and comprehensive departmental training program by identifying improvements to the existing training curriculum.
  • Responsible for ensuring training requirements are up to date for manufacturing associates
  • Maintain all manufacturing areas in accordance with GxP requirements and company SOP's
  • Responsible for performing investigations, CAPA implementation and continuous improvement of production SOP's
  • Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and functions
  • Identify and mitigate risks in manufacturing operations that may impact patient safety
  • Play significant role in interviewing, hiring and training manufacturing staff
  • Responsible for developing/optimizing, implementing manufacturing systems, documentation and procedures
  • Responsible for ensuring the accuracy of the master batch record
  • Technical review of executed batch record
  • Responsible for implementing a process control strategy
  • Responsible for the execution of manufacturing related validation or characterization studies.
  • Responsible for implementing, maintaining and tracking manufacturing related key performance indicators (KPIs)
  • Accountable for executing the environmental monitoring program (EM) and ensuring the cleanroom remains in a state of control Secondary Responsibilities:
    • Management and oversite of a Contract Manufacturing Organizations (CMO)
    • Oversite of monoclonal antibody (mAb) production at CMOs
    • Technology Transfer of cell product or mAb process
    • Review and edit relevant modules in regulatory filings (i.e. INDs and BLAs)
    • Perform additional job-related duties as required Minimum Requirements
      • A bachelor's degree in the science field with a minimum of 2 years of direct supervisory experience with 5+ years of experience in cell therapy, gene therapy, or cell processing.
      • Previous experience leading and manufacturing processes within a cGMP/cGTP compliant biotech, cell processing (i.e., somatic cell or bone marrow processing), or tissue bank facility
      • Understanding of applicable regulations and standards for processing of cellular therapy products for Phase I, II, and III trials (GMP, GTP, AABB, FACT)
      • Extensive experience in GMP cleanroom operations, including aseptic processing Background in common cell processing equipment and techniques including use of CliniMACS, preparation of sterile media, and aseptic technique
        • Strong leadership skills with ability to motivate staff members and develop a culture of operational excellence
        • Strong technical writing skills, including preparation of validation and qualification documents and batch records
        • Demonstrated ability to effectively manage performance Additional Qualifications
          • Ability to work effectively in a fast-paced, rapidly changing environment
          • Excellent people skills, with demonstrated ability to manage a diverse team and communicate effectively across functional groups
          • 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 Talaris is an equal opportunity employer and prohibits unlawful discrimination.

Keywords: Talaris Therapeutics, Louisville , Supervisor, Manufacturing Operations, Other , Louisville, Kentucky

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