The Scientist will support the development, validation, transfer of cell-based, potency analytical methods in support of cell and gene therapy product development and analytical testing. This role presents a unique opportunity within the Testing and Analytical Services Department to grow diverse technical and intellectual skills in a dynamic and fast-paced environment. We are seeking an individual who is motivated by our mission, is highly organized, and a team player that is flexible to support a range of projects within a fast-growing organization. The ideal candidate will be able to function independently or in a team setting, be goal oriented, organized, highly communicative, and able to contribute to several projects.
· Conduct bioassay method development to evaluate the functionality and potency of cell and gene therapy products.
· Under minimum supervision develop, optimize, and qualify analytical methods to characterize cell therapy products.
· Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.
· Design, execute and interpret experiments to meet R&D objectives.
· Develop presentations and effectively communicate technical results to internal technical groups.
· Maintain an up-to-date lab notebook.
· Perform and coordinate analytical testing in support of process development, manufacturing, cGMP investigations, and product characterization.
· Collaborate with a diverse team to develop products for cell and gene therapy applications.
· Draft technical reports to comply with good laboratory practices.
· Generate, analyze, and record high-quality data using documentation, and database tools.
· Participate in the support of analytical activities including method qualification, data trending, troubleshooting, optimization, review and reporting.
· Review, interpret and communicates data cross-functionally within the organization.
· Attend, participate in, and present results at cross-functional team meetings.
· Author reports and source documentation to support regulatory filings.
- Bachelor’s Degree in Biology, Biochemistry, Cell biology, Molecular Biology, Immunology, or related discipline with >8 years of relevant industry experience, or a Master’s degree with a minimum of 3 years industry experience preferred.
- Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
- Experience developing and qualifying potency methods required.
- Cell and gene therapy experience preferred.
- Prior experience with human cell isolation, aseptic technique, cell culture and banking, ELISA/MSD/ELISpot, or flow cytometry is highly desired.
- Demonstrated ability to conduct and interpret experiments to meet technical objectives
- Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
- A proven ability to collaborate with team members to complete projects in an efficient and timely manner.