Senior Scientist - Bioassay Analytical Development

JOB SUMMARY:

The Scientist Bioassay-Analytical Development will be responsible for developing new assays and testing activities relating to gene therapy candidates to enable their cGMP production and release. This individual will work in partnership with Pre-Clinical Development, Upstream/Downstream Process functions, and Quality. In this role the individual will develop and qualify new assay methods, including ELISA and in vitro cell-based assays.

PRIMARY RESPONSIBILITIES:

• Develop ELISA and Cell-based assays for identity, quantitation and potency analysis of AAV in-process, drug substance and drug product
• Collaborate with other scientists to identify areas of improvement
• Execute test methods in support of process development and development vector characterization
• Support Quality Control with qualification of analytical test methods and identify needs for release testing
• Evaluate emerging technologies for characterization of AAV and process intermediates and implement as needed
• Author documents in support of manufacturing activities
• Collaborate with other scientists and routinely present data
• Perform other duties as necessary

EDUCATION REQUIREMENTS:

• BS or equivalent with 10 years relevant experience, MS degree or equivalent with 8 years relevant experience, PhD or equivalent with 5 years relevant experience

SKILL REQUIREMENTS:

• Experience with Development of ELISA and Cell-based Assays
• Experience with various binding platforms such as BLI or SPR
• State of the industry analytic knowledge
• Experience in working in a multi-disciplinary team environment.

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics' fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.