Careers

Synlogic Therapeutics is an innovative biopharma company in Cambridge, MA. Based on the tools and principles of synthetic biology, we are driving development of a novel class of living medicines, called Synthetic Biotics. We offer a dynamic work environment where our dedicated team pursues R&D activities spanning drug discovery through clinical development. We are committed to the service of patients, to the pursuit of innovation and to maintaining a vibrant and welcoming culture.

Full-time Opportunities:

Director/Senior Director Program Management

Job Description

Synlogic is a leading biotechnology company located in Cambridge, MA, that engineers Synthetic Biotic medicines, a new class of medicines, designed from natural probiotic bacteria that are programmed to correct disease-causing metabolic dysregulation while operating within the microbiome. We are utilizing state-of-the-art synthetic biology and microbial genetics technologies to build a promising portfolio of investigational clinical candidates.

Position Description:

Synlogic is seeking a Director/Sr Director of Program Management to join their team. Reporting to SVP of Translational Sciences, this individual will help build a Program Management function focused on creating scientifically driven program managers and leaders. Supporting early stage teams in a new platform of programs, this function must assure that teams are aligned on goals, have excellent cross-functional communication and integration of activities, and manage to timelines and budget while driving from a strong scientific foundation. Alliance management skills and experience working with external partnerships is an important skill for this role. The successful candidate will both lead a cross functional team as well as build functional capabilities in the organization for timeline and budget management.

This is a unique and exciting opportunity to help develop Synthetic Biotic medicines as treatments for immune system, immune oncology and metabolic diseases.

Primary Responsibilities include:

  • Establish and direct R&D program management processes including prioritization of key project objectives, go/ no go decisions, data review based on key milestones and assist in the compilation and tracking of program budgets to maximize value of the assets in alignment with the company’s goals and objectives. This position will also have a key role in identification of key resource gaps and program risks, implementation of mitigations plans and development of product development contingency plans.
  • Develop and implement timelines (Gantt charts), project status reports, agenda, meeting minutes and timelines for tracking of interdependencies of project deliverables.
  • Support the executive staff with the development and tracking of project goals and deliverables within the context of the corporate goals.
  • Development of governance processes to enable efficient and effective decision making.
  • Development of project plans and deliver results while adhering to pre-determined budgets and timelines. Works with finance to assist in the development of project budgets and tracking project costs.
  • Understands the cross functional interdependencies to advance programs from discovery through clinical development.
  • Provide periodic status reports to executives and coordinate documentation and archiving of project deliverables and key decisions.
  • Build and drive project teams through clear designation of team and individual roles and responsibilities.
  • Communicate effectively across all functional areas so that all deliverables and interdependencies are clear.
  • Proactively identifies project challenges such as resource, technical and scheduling constraints and assists in their resolution via risk assessments tools.

Requirements for this role:

  • PhD or MS in Biology, Biochemistry, Microbiology, Immunology or related field with 10+ years of pharmaceutical industry experience
  • 5+ years experience leading/managing cross-functional development teams through clinical development and regulatory filings
  • Exceptional leadership, interpersonal communications, across all levels within the organization
  • Excellent judgement in making trade-off decisions for program scope, costs and strategy
  • Mastery in use of Program Management tools to assure clear communication and coordination of cross-functional team activities and accountability, and achievement of agreed upon company goals and timelines
  • Experience with managing regulatory submissions
  • Fosters collaboration and positive team environment
  • Experience with biologics or rare disease drug development programs desirable

To apply for this position please contact Caroline Kurtz at caroline@synlogictx.com

 

Director of Bioanalytical

Job description

At Synlogic, our vision is to create an entirely new modality of therapeutic agents – engineered probiotic bacteria that operate as living medicines to treat important diseases. We are making this dream a reality with the advancement of several projects towards clinical development, and are looking to strengthen our talented team with the addition of an experienced scientific leader to help evolve our bioanalytical strategy.

We are seeking an experienced individual who is excited by the prospect of establishing DMPK models for a new class of therapeutic agents.  This individual will have experience working across the drug discovery and development continuum, including a track record of successfully managing R&D portfolio workflows through a combination of internal resources and CROs, as well as an ability to support regulatory interactions and related document preparatory processes. The successful candidate will have expertise in small molecule bioanalytical method development strategies and instrumentation (LC-MS/MS and GC-MS) as well as establishment of appropriate assays to support discovery and early clinical development.  Importantly, this individual should have metabolomics experience including untargeted metabolite identification and characterization. Strong supervisory and communication skills and the ability to facilitate constructive, expedient problem solving are also essential, as are excellent writing and editing skills with an attention to detail. A PhD with 7-10 years of industrial experience are required.

To apply for this position please contact Paul Miller at paul@synlogictx.com

 

Scientist III Analytical Development

Position Description:

The Scientist in Analytical Development will support the development of drug substance and drug product at Synlogic. The scientist will be responsible for development of assays to support development of products and processes at Synlogic. 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. As part of this effort, the person will be expected to:

  • Develop and execute plans for development of assays to support internal product, process and formulation development.
  • Develop pre-qualification data packages for tech transfer to CDMOs and support assay qualifications as required for contracted development and GMP production.
  • Work collaboratively with the Research Analytical Group to develop assays that are suitable for process development and GMP lot release.
  • Concisely communicate assay development project objectives, advances, challenges and timelines to project teams.
  • Write and review development technical protocols and technical reports documenting analytical method development studies as required for internal documentation.
  • Write and review work documenting analytical development studies as required for IND and other regulatory submissions.

Required Technical Skills:

The applicant must have demonstrated experience with the majority of the following analytical methods:

  • Quantitative assays for enzyme kinetics, such as metabolite consumption or conversion
  • Quantitative HPLC (RP, IEX, and SEC),
  • UV-Vis and other spectrophometric plate-based assays
  • Qualitative assays including SDS-PAGE, 2D SDS-PAGE, and Western Blot
  • Quantitative and qualitative qPCR/PCR techniques
  • In vitro and cell-based assays including flow cytometry
  • LC/MS based assays

The applicant must have demonstrated experience in the following scientific areas:

  • Knowledge of the requirements and experience qualifying/validating assays for cGMP products and supporting method transfer between laboratories.
  • Familiarity with computer software including word processing and data evaluation (SigmaPlot, GraphPad, Origin, and/or JMP DOE software).
  • 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.

Education and Work Requirements:

  • D. in Analytical Chemistry, Chemistry, Biochemistry or related discipline.
  • Minimum of 5 years relevant assay development experience for cGMP products.
  • Experience independently leading analytical development projects.

 

If interested, please contact: Richard M. Schwartz, Senior Vice President, Development and Manufacturing, Synlogic Phone: 607-202-9373, dick@synlogictx.com

 

Scientist III – Downstream Process Development

Position Description:

The Scientist in Downstream Process Development will lead the development of downstream processes for drug substance at Synlogic. The Scientist will be responsible for development of processes, transfer of the processes to contract development and manufacturing organizations (CDMOs) and for monitoring those production processes during tech transfer and GMP production. 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. As part of this effort, the person will be expected to:

  • Develop and execute plans for development of downstream processes to achieve a high yield of viable Synthetic Biotic medicines as drug substances. This work will be a performed in the lab with other staff in the process development group and at CDMOs.
  • Develop and execute plans to supply purified product for formulation development support and non-clinical studies.
  • Support the evaluation and selection of contractors for the development and GMP manufacturing of Synlogic products.
  • Lead the downstream tech transfer and production of Synlogic products at CDMOs.
  • Prepare timelines and evaluate equipment needs for downstream development and production related activities.
  • Lead downstream development projects and represent the downstream work in cross-functional team meetings.
  • Write and review development technical protocols and technical reports documenting downstream development studies as required for internal documentation and tech transfer.
  • Write and review work documenting downstream development studies and GMP processes as required for IND and other regulatory submissions.

Education and Experience Requirements:

  • D. in Biochemical or Chemical Engineering, Biochemistry or related discipline with a minimum of 5 years biotech/pharma industry experience post-Ph.D. in downstream process development.
  • Experience independently leading multiple downstream development projects.
  • Confident oral and written communication skills.
  • Experience transferring processes for GMP manufacturing
  • Experience working directly with CDMOs and/or other vendors
  • Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams

Required Technical Skills:

The applicant must have demonstrated experience with the following downstream process unit operations:

  • Clarification/filtration for harvest and recovery
  • Centrifugation, including semi-continuous centrifugation
  • Ultrafiltration/diafiltration
  • Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical approaches and analysis using Design-of-experiment (DOE) approaches
  • Scale down studies, process range range studies and process robustness studies

If interested, please contact: Richard M. Schwartz, Senior Vice President, Development and Manufacturing, Synlogic Phone: 607-202-9373, dick@synlogictx.com

 

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