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Principal Analyst, Quality Control Raw Material (100% ONSITE)

Company: Seres Therapeutics, Inc.
Location: Cambridge
Posted on: August 3, 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.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
At Seres, we're leading the microbiome revolution and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics.
The position will offer the opportunity to learn cutting-edge laboratory technologies and cGMP analytical skills in a highly collaborative environment. We are seeking a highly motivated individual who will be responsible for performing inspection, sampling, testing, and labeling of raw materials according to established procedures and specifications. The QCRM Associate will require understanding of compendial requirements (USP, EP, ACS, NF) as they relate to Raw Material testing. This position also includes responsibility of authoring technical reports and raw material specifications. Additionally, the position will also offer the unique opportunity to collaborate with teams in other functional areas across the CMC organization, including Analytical Development, Bioprocess Development, Formulations Development, Supply Chain and Quality Assurance, among others.
What You'll Do

  • Inspection, sampling, testing, labeling and release of raw materials and SU components for clinical and cGMP manufacturing.
  • Review raw data and results from contract laboratories for raw materials testing.
  • Knowledgeable of wet chemistry, FTIR, Raman, and other compendial assays.
  • GMP quality systems; initiate, review and manage to completion deviations, CAPAs and Change Controls as required.
  • Troubleshooting of inspection and sampling atypical results and perform OOS investigations as required.
  • GMP documentation; SOP's and material specifications generation, revision, and approval.
  • Active member of cross-functional teams with Supply Chain, Quality Assurance, Manufacturing, Bioprocess, and external CMO/CTOs.
  • Knowledgeable about material qualification and raw material risk assessments

    What You'll Bring

    Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
    Ability to work around chemicals (if working around the laboratories)
    Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
    Ability to walk and stand for periods of time

    You May Also Bring

    • BA/BS in Chemistry, Biochemistry, Microbiology, Biology or other related field with 5+ years of GMP experience within Raw Materials
    • Demonstrate knowledge of USP, EP, JP monographs
    • Knowledge in method qualification for compendial materials
    • Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
    • Collaborative team player who fosters open communication and builds relationships with stakeholders
    • Ability to drive for continuous improvement and results-driven
    • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact with all levels.
    • Ability to handle multiple assignments and changing priorities.
    • Positive, proactive approach to drive assignments/tasks to completion *
    • Working knowledge of MS Office Suite and office productivity software and the ability to quickly learn new software; Experience with the use of Electronic Laboratory Notebooks/LIMS is a plus

      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.

Keywords: Seres Therapeutics, Inc., Cambridge , Principal Analyst, Quality Control Raw Material (100% ONSITE), Professions , Cambridge, Massachusetts

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