Our client is on the cutting edge of cell & gene therapy and they are growing! They are a mid-sized public company, located in Cambridge and have a well-respected leadership team. They are seeking an experienced PhD to join their Analytical Development group with a focus on cell-based assays.
The main function of this role is to lead development of in process and release cellular analytical assays, including molecular and flow cytometry based assays.
Responsibilities include but are not limited to;
• Development of cellular assays to support cell therapy programs
• Perform data compilation, analysis, and drafting of technical reports and methods to support development of cellular assays for clinical manufacturing
• Work with Process Development to develop understanding of cellular product critical quality attributes (CQA) to guide safe and effective clinical testing and process control strategies
• Assist with the technical transfer of cellular assays to Manufacturing or external CMOs and QC laboratories.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have an advanced degree (PhD preferred but will also consider experienced MS candidates) and must be experienced with development and transfer of qualified assays for cellular products derived from different lineages of immune and/or stem cells. Must have experience with molecular biology methods (including designing and running ddPCR and analysis of next generation sequencing), ELISA, mammalian cell culture.
Experience with designing and running multi-color flow cytometry is greatly preferred. Experience with development, qualification/validation and/or technical transfer of GMP analytical methods for cellular therapies is also greatly preferred.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.