Adicet Bio is seeking a Sr. Research Associate, Quality Control to perform QC analytical method qualification, execute sample analysis, and other assigned tasks to support the advancement of their product pipeline for autoimmune diseases and cancer.
Requirements
- Hands-on experience in cell culture, cell-based assays and immunoassays is required.
- Hands-on experience in multi-parameter/multi-color FACS assays is required.
- Hands-on experience with PCR and qPCR is desired.
- Experience working in a regulated environment is highly preferred.
- Experience in writing SOPs is preferred.
Responsibilities
- Perform flow cytometry, ELISA, cell-based assays, qPCR, and other analytical assays to enable the characterization, in-process and release testing and stability monitoring of viral vector and cell therapy products.
- Support analytical method development, qualification, and technical transfer to Contract Testing Laboratories (CTL) and Contract Development Manufacturing Organizations (CDMO).
- Support management of CTL and CDMO analytical activities.
- Function as a subject matter expert in technical discussion, document review, and investigation.
- Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method qualification protocols and reports, standard operating procedures (SOP).
- Perform data analysis and present results to the team.
- Work with QC team to maintain QC lab operation in GMP compliance.
Other
- BS or MS in biological sciences or a related field is required.
- 2+ years of relevant experience in Pharmaceutical or Biotechnology industry is required.
- Ability to work independently, multitask and meet deadlines in a fast-paced environment.
- Highly motivated, organized and detail oriented.
- Excellent computer, verbal and written communication skills.
