Associate Director, Analytical Development- Separation Assays

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. ” 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.

Key Responsibilities

Lead a team tasked with developing analytical strategy for CE- and HPLC-based AAV gene therapy vector release and characterization. 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 and 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.

Responsibilities

required 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 Chromatography, ELISA, Capillary Electrophoresis strongly 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 systems, plasmid DNA, or RNA products a plus Late-stage method development and regulatory experience 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. Work Environment 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. Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.