Job Description

The Research Associate /Associate Scientist in Analytical Development will be responsible for the analytical method development (in-process, release and characterization) and performing in-house testing within Synlogic’s CMC organization. The individual will be also responsible for preparing technical development protocols and reports for internal documentation and regulatory filling purposes. Additionally, the individual will be expected to work collaboratively with CMO/CRO testing labs to ensure an adequate clinical supply.

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

  • Develop various in-process and release/stability assays to support internal live biotherapeutic process development and formulation studies
  • Run phase-specific assay (pre-) qualification for tech transfer to external labs
  • Represent analytical development and work collaboratively in cross-functional development teams
  • Summarize and present the understanding of LBP product characterization and process control strategies

Required Technical Skills

The applicant must have demonstrated experience with several of following skills:

  • Analytical development on biologics: such as U/HPLC, CE, gel-based assays
  • Microbiology assays: such as CFU, bioburden assays
  • Molecular biology assays: qPCR/PCR
  • Experience with designing and executing analytical assay qualification/transfer to QC labs
  • Experience with probiotic and 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 per standard operating procedures
  • Detail oriented in recording and analysis of data
  • Confident oral and written communication skills
  • Demonstrated ability to work on multiple projects

Education and Work Requirements

  • BS, MS in the Pharmaceutical/Analytical Sciences, Microbiology, or related discipline.
  • Minimum of 2-3 years of relevant analytical development experience.

 

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.