We are seeking a highly motivated Scientist to join our Analytical Development team. The selected candidate will be responsible for characterization of our BOXR T cell products and development of in-process and release assays to support process development and manufacturing. The successful candidate will work in a highly cross-functional manner with members of Research, Translational Medicine, Process Development and Manufacturing as well as with external CROs
Key Activities and Responsibilities:
- Use state-of the art cellular, proteomic and molecular tools to assess key attributes of the BOXR cellular therapy product
- Select, design and implement analytical methods to test process intermediates, drug substances and drug products
- Support specification setting, qualification and validation of assays
- Write protocols and development reports, and contribute to relevant regulatory filings
- Tech transfer selected assays to in-house and CMO QC groups
- Present scientific results in team meetings and at conferences
- Other duties as assigned
Competences, Skills and Qualification:
- PhD in the biological sciences with minimum of 2 years, MS with 6 years or BS with 10 years in assay development in biotech, or equivalent experience
- Expertise in flow cytometry required
- Experience with techniques in molecular biology, such as RT-PCR and/or protein analyses (ELISA, western blot) highly desired
- Experience with assay qualification and validation and familiarity with FDA, ICH and GMP guidelines is a plus
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Strong organizational and record-keeping skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Prolonged periods of sitting at a desk, standing in a lab and working on a computer.
- Ability to safely travel to various physical locations.
- Must be able to lift 15 pounds at times.