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 Analytical Development will be responsible for the analytical method development (in-process, release and characterization), tech transfer and performing in-house testing within Synlogic PDMS organization. The individual will be also responsible for preparing technical development protocol/report for internal documentation and regulatory filling purpose. Additionally, the individual will be expected to work collaboratively with CMO/CRO testing labs to ensure clinical supply.

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

  • Develop various in-process and DS/DP release/stability assays using H/UPLC, plate reader or other analytical platforms to support internal live biotherapeutic product process development and formulation studies
  • Develop phase-specific assay (pre-) qualification data packages for tech transfer to external CMOs/labs
  • Represent analytical and work collaboratively in cross-functional development teams
  • Summarize and present the understanding of LBP product characterization and process control strategies

Duties and Responsibilities

  • Analytical chemistry experience for biologics: such as U/HPLC, CE, Gel-based assays
  • Analytical assay development, optimization and continuous improvement experience for GMP clinical and/or commercial products
  • Experience designing and executing analytical assay qualification and tech transfer to QC labs
  • Molecular biology assay and cell-based assay experience will be a plus
  • Experience with probiotic and/or cell/gene therapy assays will be a plus

The applicant must have the following skills:

  • Ability to quickly learn and perform various analytical tools and test methods
  • Ability to perform analytical testing in a GxP compliant laboratory
  • Detail oriented in recording and analysis of data with statistical tools
  • Confident oral and written communication skills
  • Demonstrated ability to work on multiple projects
  • Ability to independently plan and execute scientific plans with minimal supervision

Qualifications & Experiences

  • BS, MS in Pharmaceutical or Analytical Sciences, or related discipline.
  • Minimum of 5 years of relevant industry CMC analytical development experience.

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.