Analyst II/Senior Analyst, Quality Control

Kriya Therapeutics•Durham, NC

4d•Onsite

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.” This role is responsible for performing a range of Quality Control testing techniques on production facilities, intermediates, and products, and includes authoring SOPs / Protocols / Reports. This position will be hired at either the Analyst II or Senior Analyst level; scope of ownership and level of independence will align with the successful candidate's experience.

Requirements

BS/Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, or related field.
3+ years of experience in a cGMP, QC, or a similar laboratory environment is required (4+ years preferred for consideration at the Senior Analyst level).
Previous experience performing HPLC, PCR, or cell-based potency testing is required.
An equivalent combination of education and experience is acceptable.
Strong good documentation practices.
Strong technical writing skills.
Excellent verbal and written communication skills, detailed-oriented personality.
Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

Nice To Haves

Previous experience in gene therapy is preferred.
Experience training and/or mentoring laboratory analysts preferred.

Responsibilities

Performs routine and non-routine cGMP testing for samples, as well as provide primary support for training and mentoring of laboratory personnel, as needed.
Leads, develops, and executes QC methods across a range of techniques, including HPLC, CE, PCR, and cell-based potency methods.
Verifies and reviews QC data.
Leads project work and deviations, investigation, CAPAs and continuous improvement initiatives.
Serves as SME for certain assays / instruments / equipment.
Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, and sample handling/tracking).
Participate in GMP validation activities for laboratory equipment, including the onboarding and execution of IQ/OQ/PQ Testing.
Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits.