Scientist III, Analytical Development- HPLC Based Assays

Description

Role Overview

• Develop chromatographic, electrophoretic and ELISA-based analytical methods for identity, quantitation and purity analysis of AAV in-process, drug substance and drug product.
• Collaborate with other scientists to identify areas of improvement.
• Review and approve ELN entries for other group members.
• Execute test methods in support of process development and development vector characterization.
• Support Quality Control with qualification/validation 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.

Experience & Skills and Work Environment

• BS or equivalent in Science, Biotechnology, Engineering or other related field with 10+ years of industry experience.
• Master’s degree with 6+ years of industry experience.  
• PhD with 4+ years of industry experience.
• Experience with analytical techniques including Chromatography, ELISA, Capillary Electrophoresis strongly preferred.
• In-depth experience of the development, qualification, and implementation of analytical methods for the characterization and release testing of AAV vectors or biologic products in an industry setting strongly preferred.
• Relevant AAV gene therapy experience in leading analytical development is preferred.
• Previous experience with development of analytical methods supporting late-stage clinical manufacturing is a plus.
• Experience with characterization and release testing of viral vector-based systems, plasmid DNA, or RNA products is a plus.
• Sound understanding and demonstrated application of statistical methods/tools.
• Strong verbal, written, and interpersonal communication skills.
• Self-motivated, organized, capable of working independently and in a collaborative environment.
• Exercise of discretion and independent judgment.
• Ability and desire to work in a fast paced, startup environment.
• An ability to build effective relationships and work cross-functionally to deliver results and meet business objectives.

• Primarily a desk setting but may include laboratory work.
• May involve standing, sitting, and using laboratory equipment for extended periods.
• Must have flexible work hours, and be willing to work outside of normal, schedule hours; as necessary.

Life at Kriya

• Time Off & Work-Life Balance: Flexible Time Off Paid Parental & Medical Leave Paid Company Holidays
• Health & Wellness:  Fertility & Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage
• Financial Security:Equity 401(k) with Company Match Identity Theft Protection
• And More!