Principal Research Associate-Bioanalytics
Location
Waltham, MA | United States
Job description
Position Overview:
We seek a highly motivated Principal Research Associate to join the newly formed Bioassay and Molecular Analytical Development (BAM) group within the Genomic Medicine Unit (GMU)-Bioanalytics group in Framingham, MA. This group will be moving to Waltham, MA in 2022.
The successful candidate will participate in the development, qualification, and transfer of cell-based, binding and molecular methods used for analyzing cell & gene therapy candidates in clinical development, including cGMP release and stability testing of clinical trial material as well as critical raw materials. The ideal candidate will have an innovative mindset, excellent communication skills, and a proven ability to work with a high level of integrity, accuracy, and attention to detail.
Key Responsibilities:
Work under minimal supervision to develop and implement cell-based assays for potency and other parameters per ICH and regulatory guidelines.
Perform cGMP sample testing by following method protocols (SOPs) and ensure timely completion and delivery of analytical results. Generate data packets supportive documentation (ELN, technical reports, SOPs, etc.) as required.
Work within a broader team to evaluate and implement new technologies and ways of working to enable agility and innovation in the workflow.
Serve as a technical resource to solve analytical method and instrument issues. Present technical work internally and externally.
Work collaboratively with other teams within GMU such as Process development, Research and Quality teams.
Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).
Basic Qualifications:
Masters degree in a life science discipline with a minimum of 2 years of relevant industry experience or Bachelors degree in a life science discipline with a minimum of 4 years of relevant industry experience.
Experience using and developing cell-based assays with readouts such as ELISA, PCR or flow cytometry.
Excellent verbal and written communication skills.
Preferred Qualifications:
Hands-on experience with development and validation of ELISA, PCR based-Bioassays and flow cytometry methods in a GxP setting.
Familiar with QbD principles and Design of Experiment approaches for method development/optimization.
A minimum of one years experience in a cGMP environment.
Employment Type: Full-Time
Job tags
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