Company Overview

At Synlogic: We are Putting LIFE Into Medicines
We are pioneers in the development of Synthetic BioticTM medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer.

Every day our teams work tirelessly to drive to deliver on 4 aspirations:

  • People: LIVING each day with passion for building up and building out our Synlogic team
  • Platform: Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
  • Products: Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
  • Promise: Building our company to launch multiple novel LIVING medicines – mastering a new frontier in medicine

We combine Human Logic and Science Logic to drive meaningful work, careers, and LIFE at Synlogic. We foster a people-focused environment grounded in: Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire: Innovation, Integrity, High Performance, and LIFE Changing Results.

We continue to build and enhance our organization. If you want a settled environment, pursuing a well-walked path then this environment is probably not for you. If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you.

Job Description

The Lead Research Associate in Microbiology (AD) will be responsible for the microbiological analytical method development (in-process, release and characterization) of clinical through commercial phase products. The candidate will design experiments for high-throughput analysis of bacterial cells for Synlogic’s live biotherapeutic products (LBPs).

Duties and Responsibilities

As part of this effort, the person will be expected to:

  • Develop assays to enumerate and characterize the viability, permeability and strength of our LBPs using CFU, flow cytometry or other methods.
  • Develop methods for the high-throughput analysis of the cells including the development of automation as required.
  • Develop phase-specific assay (pre-)qualification validation data packages for the tech transfer of microbiological assays to external CMO labs.
  • Support development of assays for characterization of aerobic and anaerobic bacteria, their molecular, morphological, and physiological features.
  • Prepare technical development protocols/reports for internal documentation and to support regulatory filings.
  • Work collaboratively with GMP CMO/CRO testing labs to ensure proper tech transfer (travel to CMO/CRO sites may be required).

 

Qualifications & Experiences

The applicant must have the following skills:

  • BS, MS in Microbiology, or related discipline.
  • 5 – 15 years of relevant hands-on experience with microbial assay development in an industry environment.
  • Experience with flow cytometry and PCR/qPCR assays is required.
  • Microbiological analytical/QC experience with assays such as colony forming unit (CFU) and bioburden enumeration is required.
  • Experience with assay qualification/validation per ICH Q2(R1) is required
  • Familiarity with high throughput technology, including automated sample processing using liquid handling stations is highly beneficial
  • Experience with aerobic and anaerobic bacterial assays is beneficial
  • Experience with analysis of bacteria by flow cytometry preferred
  • Knowledge of the requirements and experience qualifying/validating assays for cGMP products and supporting method transfer between laboratories
  • Confident oral and written communication skills
  • Proficiency in writing and reviewing method qualification/validation protocols and reports, method transfers,
  • SOPs, QC data packets and other process documents
  • Demonstrated ability to work on multiple projects

Other Requirements

Behaviors

We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results. Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.

Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting. Our compassion for each other creates a safe environment for continuous risk taking and personal development. We connect with our colleagues by having fun together. We take our work seriously and value integrity in producing the highest quality work. We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team. We encourage openness, direct feedback and transparency in decision-making to enable trust and maintain the nimbleness of the group.

TO APPLY

To apply for this position please send your resume to: joinus@synlogictx.com

Synlogic, Inc. is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.