Associate Director, Analytical Development- Separation Assays

Kriya Therapeutics • Morrisville, NC

10h • Hybrid

About The Position

Kriya is a biopharmaceutical company focused on developing life-changing gene therapies for diseases with high unmet needs, particularly in metabolic disorders, neurology, and ophthalmology. The company utilizes a proprietary computational engine, in-house manufacturing, and an integrated design platform. The Associate Director, Analytical Development will lead AAV gene therapy vector characterization, method development, optimization, and pre-validation efforts. This role involves building and leading a team responsible for developing and optimizing analytical methods for late-phase programs, as well as strategic planning, development, and transfer of these methods to the QC department.

Requirements

• Master's degree in Science, Biotechnology, Engineering or other related field
• 5+ years of progressive experience with management 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
• 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
• An ability to build effective relationships and work cross-functionally to deliver results and meet business objectives.

Nice To Haves

• PhD preferred
• 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
• Ability and desire to work in a fast paced, startup environment

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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager