Scientist/Sr. Scientist – In-Process Analytics and Characterization

Summary

The Scientist will support the development, transfer, bridging, monitoring, and execution of analytical methods in support of cell and gene therapy process development and analytical testing. This role presents a unique opportunity within the Process Development 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.

Responsibilities

• Conduct method development, transfer, bridging, monitoring, and execution to support Process Development with robust in-process analytics and characterization.
• Under minimum supervision develop, optimize, and execute analytical methods to evaluate cell and gene therapy products.
• Maintain analytical instrumentation and contribute to the organization of reagent stocks, instruments, and documentation.
• Design, execute and interpret experiments to meet 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.

Qualifications

• Bachelor’s Degree in Biology, Biochemistry, Cell biology, Molecular Biology, Immunology, or related discipline with >8 years of relevant industry experience, a Master’s degree with a minimum of 3 years industry experience, or a PhD preferred.
• Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a Process/Analytical Development laboratory environment preferred.
• Experience developing, transferring, and executing methods required.
• Cell and gene therapy experience preferred.
• Prior experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics 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.