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 Analytical Development Lead Scientist will lead phase-appropriate analytical development strategy for potency and characterization of live biotherapeutic product candidates within the CMC function. The scientist will be part of a dynamic and motivated Development team to bring Synlogic’s novel Synthetic Biotic™ medicines to clinical trials and eventual commercialization. This position requires in depth experience and knowledge in biological analytics with an understanding of biological potency assays as well as U/HPLC and plate-based assays. This person will be responsible for providing critical expertise in a cross-functional CMC team.

Duties and Responsibilities

  • Lead the clinical phase-specific development of biological assays such as product potency and establishment of product specifications
  • Lead the development of cell-function relationships and analytical characterization of the Synthetic Biotics™ to define critical quality attributes of the drug substance and drug product
  • Support the development of analytical correlations to process variables and recommend PAT strategies as appropriate.
  • Manage a team to perform assay development and testing to support high-throughput potency testing of internal process and formulation development samples and implement assay automation as needed
  • Lead the test method generation, tech transfer and qualification/validation to support GMP manufacturing for assays developed by the candidate
  • Provide analytical guidance to support manufacturing investigations
  • Prepare technical reports for all development activities
  • Support preparation of regulatory submissions, participate in their review and approval, and contribute in the development of strategies to comply with US and international regulatory standards
  • Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example.
  • Represent analytical development and work collaboratively in cross-functional development teams. Concisely communicate assay development project objectives, advances, challenges and timelines to project teams.

Qualifications & Experiences

Required Qualifications & Experiences: The following qualifications and experiences are required for the position:

  • Ph.D. in microbiology, biochemistry or related discipline with at least 5 years of experience in biopharmaceutical analytical development for clinical and/or commercial-stage biological products
  • Experience developing quantitative assays for enzyme kinetics, such as metabolite consumption or conversion for use as potency assays
  • Experience developing quantitative U/HPLC assays (e.g. RP, IEX, and SEC)
  • Experience developing quantitative UV-Vis and other spectrophometric plate-based assays
  • Demonstrated experience qualifying/validating assays per ICH Q2(R1)
  • Prior experience transfering test methods to GMP QC labs for biological products
  • Experience with regulatory submission writing and review (ie: INDs, BLAs, etc)
  • Excellent oral and writing skills

Preferred Qualifications & Experiences: The following qualifications and experiences are preferred:

  • Experience with assays for live biotherapeutic products or probiotics
  • Understanding of microbial genetics and biology with knowledge and application of transcriptomics, proteomics and metabolomics is highly beneficial
  • Automation of assays using liquid handling stations for high-throughput use in R&D
  • Quantitative and qualitative qPCR/PCR techniques
  • Analytical development on biologics such as SDS-PAGE, CE, ELISA and gel-based assays
  • In vitro and cell-based assays including flow cytometry
  • Assays for solid dosage forms of drug substance and drug product for lot release and characterization

 

Other Requirements

  • Travel to CMOs for tech transfer of assays is expected to be required

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.