JOB DESCRIPTION

The Lead Research Associate/Engineer in Formulation Development will support the development of drug substance and drug product at Synlogic. The individual will be responsible for 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.

RESPONSIBILITIES / DUTIES:

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
  • Perform lyophilization studies to support cycle development, scaleup, and process validation by establishing process design space
  • Execute studies to evaluate other drying approaches such as spray drying or fluid bed drying
  • Execute studies to contribute to the development of solid oral dosage forms for the dried product
  • Assist with tech transfer from development to manufacturing and with GMP manufacturing campaigns by contributing to the development of batch records
  • Write and review technical protocols and reports documenting formulation studies and analytical data

QUALIFICATIONS & EXPERIENCES:

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

  • Experience with lyophilization is required. Experience with other drying approaches such as spray drying or fluid bed 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 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 quickly learn and perform unit operations and analytical methods
  • Ability to operate independently in a laboratory setting and as part of 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

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

  • B.S. or M.S. in Pharmaceutics, Chemical Engineering, or related discipline.
  • Minimum of 5 years of relevant formulation and/or analytical development experience.

OTHER REQUIREMENTS:

Occasional travel may be required.

 

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.