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 Scientist/Sr Scientist in Formulation Development will support the development of drug substance and drug product at Synlogic. The individual will be responsible for designing and performing unit operations related to drying of drug substance formulations for live biotherapeutic products and supporting development of solid oral dosage forms. Additionally, the individual will be responsible for performing analytical characterization to enable the development of the formulations.

Duties and Responsibilities

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

  • Design and execute studies for the development of stable lyophilized formulations of live bacteria
  • Generation of analytical data to support lyophilized formulation and process development
  • Lead, design, and execute lyophilization studies to support cycle development, scaleup, and process validation by establishing process design space
  • Manage the execution of studies at CMOs/CROs that will efficiently lead to development of formulations
  • Execute studies to evaluate other drying approaches such as spray drying and identify new drying technologies that may allow for more rapid advancement of the Synlogic platform
  • Design studies for the formulation development of stable frozen liquid formulations for live bacteria
  • Execute studies to contribute to the development of solid oral dosage forms for dried product
  • Assist with tech transfer from development to manufacturing and with GMP manufacturing campaigns by contributing to the development of batch records and batch release
  • Provide scientific input and advice for cross-functional project teams, identify potential hurdles for formulation development in project timelines, and design studies to proactively address these hurdles
  • Write and review technical protocols and reports documenting formulation studies and analytical data
  • Contribute to the CMC sections of IND and BLA regulatory filings

 

Qualifications & Experiences

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

  • Ph.D. in Pharmaceutics, Chemical Engineering, or related discipline with 3-5 years of relevant experience in formulation and process development
  • Experience with lyophilization is required. Experience with other drying approaches such as spray drying is a plus.
  • Experience with biologics is required. Experience with live biotherapeutics and microbiological assays is a plus.
  • Experience with analytical methods such as plate based assays, Karl Fischer, and thermal analysis to support lyophilization development is required.
  • Experience with development of frozen liquid and solid oral dosage forms is a plus.
  • Experience with statistical analysis and design of experiments (DoE) is required.

The applicant must have the following skills:

  • Ability to lead, design, and execute studies for the optimization of unit operations related to drying processes and development of a solid oral dosage form
  • Ability to operate independently in a laboratory setting and the ability to lead a collaborative team
  • Detail oriented in recording and analysis of data
  • Ability to investigate, troubleshoot, and resolve issues associated with formulation studies and/or GMP manufacturing
  • Confident oral and written communication skills.
  • Demonstrated ability to multitask work to support different projects and the ability to adapt to changing timelines and priorities

Other Requirements

  • Travel to support CMOs and CROs will 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.