Senior Research Associate, Analytical Testing and QC

COMPANY:

Clinical-stage Biopharma/Gene Therapy company

LOCATION:

Greater Boston, MA area

TITLE:

Research Associate II/Senior Research Associate, Analytical Testing and QC

TYPE:

Temporary Full-time with potential to go perm after 6 months

RELOCATION ASSISTANCE:

Not available

ROLE RESPONSIBILITIES:

The Research Associate, Analytical Testing will support in the development of preclinical and clinical products based on the company's proprietary synthetic nanoparticle technology. Other responsibilities include:

• Executes routine R&D and release and stability GMP testing for API, bulk drug substance and final drug product intended for clinical supply
• Maintains and analyzes method performance trending and provides subject matter expert level peer review for analytical documentation of well-controlled analytical assays for the analysis of raw materials, drug substances and drug products
• Initiates and actively participates in completion of deviations, investigations and CAPA in compliance with GMP.
• Other duties as assigned

CANDIDATE REQUIREMENTS:

• Bachelor's degree in a relevant, scientific field with relevant industry experience
• Experience in HPLC separations including reversed-phase, normal phase and SEC with a variety of detection modes and plate-based assays including instrumentation troubleshooting is required
• Experience in writing GMP documents
• Strong knowledge and focus on GMP compliance

This is a short-term contract with the potential to go permanent. It is an excellent opportunity to gain exposure to AAV gene therapy products with a GMP environment.

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contact with further details.