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Supervisor, Laboratory Engineering (Hybrid)

Company: Seres Therapeutics, Inc.
Location: Cambridge
Posted on: March 17, 2023

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.OurSER-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
The Seres Therapeutics Global Engineering and Maintenance team is focused on manufacturing therapeutics for the microbiome and ensuring appropriate implementation of new and existing GMP (Good Manufacturing Practices) procedures and facility assets, aiding corporate manufacturing objectives. The Laboratory Engineering Supervisor will ensure that all tasks required to maintain the lifecycle of Donation Collection Facilities/Labs and Quality Control Labs equipment, and the safety of personnel, are completed in a manner consistent with company policies and industry requirements. Additionally, this individual will develop individual and team goals and objectives as well as department strategies to align with Seres' mission to expand access to microbiome therapeutics. S/He reports directly to the Sr Manager, Laboratory Engineering.
What You'll Do

  • Work closely with service vendors and asset owners to conduct full range of equipment and facility acquisition, maintenance, modifications, and decommissioning.
  • Manage a direct report(s) to support the Global Engineering and Maintenance equipment lifecycle strategy.
  • Act as SME for Laboratory equipment and support programs, as well as for satellite facilities when required.
  • Support implementation of engineering capital projects within budgets and timelines that increase the performance and reliability of plant & production equipment.
  • Ensure appropriate training of personnel on equipment, process, and facility safety procedures is maintained and up to date.
  • Build and sustain employee engagement by creating a culture of optimal execution and an environment where individuals and teams excel and continuously improve.
  • Communicate and collaborate with Donation Collection, Donor Analytics, Quality Control and Quality Assurance groups to ensure smooth integration of new equipment, policies, and priorities, or identification of necessary updates to existing systems.
  • Manage internal and external partnerships with an emphasis on excellent customer service.
  • Monitor alarms during both regular and irregular work hours (as needed)
  • Provide technical assessments on change controls, deviations, and quality investigations.
  • Work with the Quality team to apply and refine tools for Quality Risk Management
  • Identify and analyze project risks and guide working groups to develop appropriate mitigation strategies.

    What You'll Bring

    • Bachelor's degree in Science, Engineering or a related field with 4+ years of experience OR Masters in equivalent field with 2+ years of experience in biopharma clinical manufacturing or relevant industry
    • Direct experience supporting process and laboratory equipment within an FDA/EMEA regulated environment.
    • Demonstrated strong mechanical aptitude to perform basic troubleshooting and diagnostics for equipment failures.
    • Experience with building alarm systems and computerized asset management
    • Ability to perform Life cycle analysis of manufacturing documents and SOPs
    • Familiarity with industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing and GxP laboratories
    • Familiar with Laboratory equipment, analytical equipment, and lab utilities.
    • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development
    • Strong understanding and ability to apply ASTM E2500 CQV lifecycle model.
    • Strong communication skills
    • Detail oriented, independently motivated and possess strong problem-solving abilities in collaborative environments.
    • Previous management experience a plus

      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.

Keywords: Seres Therapeutics, Inc., Cambridge , Supervisor, Laboratory Engineering (Hybrid), Engineering , Cambridge, Massachusetts

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