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Manager, Quality Control Microbiology

Location: Cambridge
Posted on: November 19, 2021

Job Description:

Career Opportunities with Seres Therapeutics, Inc. A great place to work. Careers At Seres Therapeutics, Inc. Share with friends or Subscribe! Even if you don't see a job that's a fit, but you're excited by what Seres is doing and want to be a part of it, we'd appreciate hearing from you and will keep you in mind for a future opportunity.--Click here --to submit your resume.-- Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic-- microbiome therapeutics. Seres has promising late clinical stage programs for treatment of recurrent Clostridium difficile infection and Ulcerative Colitis and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria. Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including immuno-oncology and inflammation to build upon its field-leading portfolio of intellectual property and know-how. Position Summary We are looking for a proactive team player and technically knowledgeable candidate to be a Manager, Quality Control Microbiology rapid to support these exciting microbial therapies. -- Seres has developed a suite of proprietary QC analytical techniques spanning microbiology, molecular biology, and chemistry that we routinely use to release and characterize our products. As part of the role, you will have the opportunity to provide leadership and technical expertise in Quality Control operations in these novel methods and lead them to help us move our products forward to patients. Additionally, we are a highly collaborative team, and your work will support critical efforts from functions across the company, including Analytical Development/ASAT, Manufacturing/MSAT, Facilities and Engineering, and Quality Assurance. If you have a strong positive attitude and are excited about learning and applying new skills while also potentially making a difference in people's lives, this may be the role for you. What You'll Do

  • Ownership of identification, documentation, and communication of microbial identifications and the recommendation of policies, procedures, and activities ensuring that robust contamination controls are in place.
  • Oversee microbiological identification program to generate accurate, precise, trustworthy data to support clinical drug product release and stability studies
  • This position provides direction to the Microbiology department while providing Microbiological expertise and support to Manufacturing and Quality operations on-site.
  • Provide support and guidance for the resolution of investigations, deviations, CAPAs, change controls, and other quality systems issues, as appropriate
  • Analyze data and rapidly report out results and flag any assay issues or out-of-specification (OOS) results observed
  • Promote QC process improvements by authoring and updating assay SOPs and test methods as needed
  • Qualify and maintain analytical instruments for use and troubleshoot issues as necessary
  • Work with more junior staff to develop, qualify, and troubleshoot analytical methods for process monitoring and product release
  • Collaborate with outside stakeholders to ensure QC instrumentation is procured and maintained to GMP standards
  • Develop and lead a high-performing team; facilitating goal setting and development of direct reports.
  • Ensure that the QC lab is maintained to GMP housekeeping standards and according to EH&S and that all analysts are trained on this activity
  • Maintain inventory of consumables, reagents, controls and ref standards; track expiry of QC consumables to support micro identifications.
  • Proactively pursue continual improvement and procedural changes
  • Liaise with stakeholders to determine testing and shipping logistics
  • Develop and Execute on QC Operational strategy in conjunction with senior leadership.
  • Support internal and external audits, inspections and technology transfers as required.
  • Lead training sessions on QC Lab Op owned procedures to QC staff and external groups, as needed.
  • In collaboration with key stakeholders, oversee external vendors/contract testing facilities What You'll Bring
    • Proven track record of building and managing the day-to-day operations of a QC group
    • Experience executing and validating Microbiological Identification systems; MicroSeq, Maldi, etc.
    • Ability to interface effectively with management and other groups, project teams and personnel.
    • Excellent leadership skills to lead cross functional teams to ensure project success
    • Excellent interpersonal skills with ability to handle conflict effectively.
    • Team player capable of working in a fast-paced environment; Highly proactive and interested in rapidly learning new skills and helping the team
    • Strong analytical, communication, documentation, and organizational skills
    • Experience with microbiological assays (i.e. CFU, microscopy, microbiological identification), molecular assays (qPCR, etc.) and/or biochemical assays is valuable
    • 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
    • Previous experience with cGMP operations and regulations is a plus Education and Experience:
      • M.S. or B.S. BS degree in microbiology, molecular biology, biochemistry or a related discipline with a minimum of 5 year's experience in a cGMP Quality Control lab; or equivalent combination of education and experience.

Keywords: SERES THERAPEUTICS, INC., Cambridge , Manager, Quality Control Microbiology, Executive , Cambridge, Massachusetts

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