We have the opportunity to bring on a Scientist to the Analytical Development & Quality Department for at a renowned biotechnology company. This position will be in the Cell Therapy Group.
As a Bioanalytical Cell Therapy Scientist, you will be primarily developing analytical methods for cell-based assays for the cell & gene therapy products. Additional responsibilities include:
- Support Drug Substance (DS) and Drug Product (DP) process by developing, qualifying, and validating analytical methods.
- Troubleshooting to increase efficiency for method protocols.
- Author regulatory filing sections for IND and IMPD.
- Collaborating with Quality Control (QC) team for method transfer.
The ideal candidate is someone who is skilled in molecular biology and cell-based assay development, self-motivated, and organized. Additionally, you should have:
- PhD or MS with 3+ years of industry experience (GMP), OR BS with 5+ years of industry experience (GMP) with a background in immunology or analytical assays.
- Experience with analytical method validation and transferring those methods to internal groups.
- Ability to troubleshoot instrumentation issues.
*Must be fully vaccinated against COVID-19 14 days before employment start
** Must be authorized to work in the US