Research Associate II

2 weeks ago


Newton, United States STC Biologics Inc Full time

Overview: Support development of assays or formulations and participate in GMP testing of biopharmaceutical products.


Responsibilities

·      Able to execute procedures developed by others and implement existing procedures with minimal supervision

·      Understand scientific principles and details of their work 

·      Can improve/correct existing procedures (e.g., Test Methods, SOPs)

·      Run procedures with minimal rework

·      Draft buffer / reagent / formulation/ sample preparation sheets and prepare them with accuracy in calculations and measurements

·      Required to be compliant with GMP regulations

o   Execute methods and accurately document procedures in compliance with GMPs and in a timely manner.

o   Serve as a verifier during GMP testing and ensure compliance

·      Ensure applicable training is current before performing processes

·      Maintain cleanliness of the offices and work areas

·      Promptly alert management of technical, equipment, facility, project or GMP issues

·      Provide raw data and powerpoint summaries with detailed methods that are accurate, complete with required details, presentable / professional, and requiring minimum revisions

·      Able to write draft reports as needed with some interpretations that may require revisions

·      Place protocols, executed protocols/test forms, raw data/ scans in appropriate folder, organized in a traceable manner

·      Required to make accurate basic algebraic calculations (for example for making a buffer); able to plot curves

·      Assist with troubleshooting, investigations for deviations and corrective actions

·      Use and maintain equipment per operational SOPs. May be involved with equipment maintenance, calibration, and qualification

·      Perform assigned tasks with attention to safety.  Use personal protective equipment in work areas. Comply with established waste disposal procedures



Credentials and Experience

·      Bachelors in a science field with 1-3 years of laboratory experience or high school diploma with 3-6 years of laboratory experience

·      Experience with cGMPs or work in other regulated industries is preferred



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