Clinical-stage Biopharma/Gene Therapy company
Greater Boston, MA area
Research Associate II/Senior Research Associate, Analytical Testing and QC
Temporary Full-time with potential to go perm after 6 months
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
- 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.