Associate Director, Analytical Development - Cell Based Assays

Kriya Therapeutics Inc•Morrisville, NC

49d

About The Position

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.” Role Overview The Associate Director, Analytical Development will lead AAV gene therapy vector characterization, method development, optimization, and pre-validation efforts. The Assoc. Director, Analytical Development will build and lead a team responsible for developing and optimizing analytical methods in support of multiple Late-phase programs. The successful candidate will be responsible for strategical planning, developing, and transferring analytical methods to the QC department.

Requirements

PhD degree in Science, Biotechnology, Engineering or other related field and 5 years of industry experience, Master’s degree and 8 years of experience, or Bachelor’s degree and 10 years of experience
Demonstrate 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
Experience with analytical techniques including Flow Cytometry, ddPCR, ELISA, DNA sequencing and cell-based potency assays strongly preferred
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.

Nice To Haves

PhD preferred
Relevant AAV gene therapy experience in leading analytical development is preferred
Previous experience managing, coaching, and providing direction to technical staff in an industry setting is preferred
Experience with characterization and release testing of viral vector-based system potency, plasmid DNA, or RNA products a plus
Late-stage method development and regulatory experience a plus

Responsibilities

Lead a team tasked with developing analytical strategy for cell- and DNA-based AAV gene therapy vector release and characterization including potency
Contribute to science-driven, phase appropriate, and risk-based analytical development and specification setting to support all programs in the company
Serve as a subject matter expert, author and/or review relevant sections of documentation in support of INDs and other regulatory submissions
Seek out and analyze data from a variety of sources to support decisions
Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
Lead and supervise the team technically to stay up-to-date and ensure high quality analytical capability
Coordinate sample plans cross-functionally to support phase appropriate development