Research Associate/ Associate Scientist Analytical Development

Location
Cambridge, Massachusetts
Salary
Competitive
Posted
Jan 02, 2018
Closes
Jan 08, 2018
Ref
18713467
Contract Type
Full Time
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 CMC organization. The individual will be also responsible for preparing technical development protocol/report for internal documentation and regulatory filling purpose. Additionally, the individual will be expected to work collaboratively with CMO/CRO testing labs to ensure 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 biotherapeutics process development and formulation studies

* Run phase-specific assay (pre-) qualification for tech transfer to external labs

* Represent analytical and work collaboratively in cross-functional development team

* Summarize and present the understanding of LBP product characterization and process control strategies



Requirements



KEY ACCOUNTABILITIES/DUTIES:



* Analytical chemistry 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 operate analytical testing in a GxP compliant laboratory

* Detail oriented in recording and analysis of data

* Confident oral and written communication skills

* Demonstrated ability to work on multiple projects



QUALIFICATIONS & EXPERIENCES:



* BS, MS in Pharmaceutical analysis, microbiology, or related discipline.

* Minimum of 2-3 years of relevant analytical development experience.



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