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Director GxP Facilities and Maintenance (HYBRID)

Company: Seres Therapeutics, Inc.
Location: Cambridge
Posted on: September 23, 2022

Job Description:

Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. -Our -SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
Seres Therapeutics is a member of the Flagship Pioneering family of companies.
Position Summary -
Reporting to the Senior Director, GxP Facilities & Engineering (F&E), you will play a critical role in building the Seres' organization in support of both commercial and clinical manufacturing in close partnership with Quality, Manufacturing Operations and Engineering management. Working closely with the Sr Director GxP F&E and peers, this role will be responsible for all GxP utilities systems, laboratory equipment and manufacturing equipment preventative maintenance and calibration activities across the Seres network. The role will be responsible for establishing industry leading processes and capabilities in support of GMP drug supply (including global GxP facility and maintenance standards, facilities related deviations, CAPAs, and change controls, and establishing robust and compliant maintenance programs). A critical responsibility of this role will be to support the rapid growth of Seres' GxP F&E organization through leadership and mentorship of the team and attracting and retaining top technical talent. This role will be headquarter-based in Cambridge with global responsibilities, and an estimated 15% amount of travel outside of the greater Boston area per year.
What You'll Do -


  • You will be responsible for leading the rapidly growing Seres Global GxP Facilities and Maintenance team, including recruiting and employee development.
  • Lead the team responsible for establishment of global GxP facilities, clean utilities, instrumentation, and maintenance programs, standards, and procedures for the portfolio of GxP labs, donor facilities, and GMP manufacturing facilities.
  • Partner with the Validation and Quality Validation teams to ensure clean utilities and process equipment are maintained in a validated state.
  • Coordinate work performed on GxP facilities, utilities, instruments and equipment by external suppliers and vendors.
  • Lead and develop the strategy to optimize the maintenance support model for GxP facilities, clean utilities, instruments and equipment.
  • Ensure the effectiveness of the preventative maintenance (PM) and calibration program of process equipment, instruments, clean utilities and plant systems.
  • Act as SME in support of engineering capital projects, deviations, CAPA and change control as needed.
  • Support the establishment of a clear and inherent culture of Quality First and Right First Time that ensures high transparency and collaboration between Quality, Operations and MSAT such that we work daily as one team in service of bringing Seres' transformative therapeutics to patients, ensuring high quality, responsiveness and value.
  • Demonstrate and coach your team to have a continuous improvement mindset and exhibit strong accountability and technical ownership of the GxP facilities and process equipment.
  • Coach and mentor your team to achieve a high performance, quality- and safety-focused maintenance culture.

    What You'll Bring

    • Bachelors of Science degree in engineering, science, leadership or other relevant discipline plus 10+ years of GxP Facilities, Engineering, Maintenance, and/or Planning & Scheduling leadership experience.
    • GxP Facilities experience, including clean utility, instrument calibrations and process equipment maintenance, Building Management Systems (BMS), Computerized Maintenance Management Systems (CMMS).
    • Experience with budgetary ownership of asset management, GxP facilities maintenance, service contracts and spare part tool room.
    • First-hand experience participating in FDA and other regulatory agency inspections representing Facilities is required.
    • Working knowledge of FDA regulations, fundamental principles and operating implementation of electrical, HVAC, process heating and cooling utilities. - -
    • Specific knowledge of equipment reliability principles and processes as related to maintenance practices.
    • Knowledge of clean utilities purified water, water for injection, pure steam and maintenance of a GxP facility. - -
    • Strong track record in development and implementation of GxP preventative maintenance programs.
    • Strong ability to collaborate and build productive relationships with team members and stakeholders across the organization; leads by example.
    • Excellent verbal and written communication skills; ability to interface with all levels of the organization.
    • Place a strong emphasis on sustaining and improving our safety culture to help further develop existing EHS program, while simultaneously providing guidance and leadership to the Facilities and Maintenance team. - -
    • Demonstrate leadership in building and developing high-performance technical and cross-functional teams that can rise to the challenge to deliver for patients with un-met medical needs.
    • A growth mindset and passion for building something new with a talented team, in service of bringing breakthrough medications to patients.

      Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. - Newly hired employees must be vaccinated prior to their employment start date.
      Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
      #LI-AD1

Keywords: Seres Therapeutics, Inc., Cambridge , Director GxP Facilities and Maintenance (HYBRID), Professions , Cambridge, Massachusetts

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