Analyst II/Senior Analyst, Quality Control

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.”

About the Role

This role is responsible for performing a range of Quality Control testing techniques on production facilities, intermediates, and products, and includes authoring SOPs, Protocols, and 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.

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, or equipment.
• Supports operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, and sample handling/tracking).
• Participates in GMP validation activities for laboratory equipment, including the onboarding and execution of IQ/OQ/PQ Testing.
• Ensures continuous lab compliance with applicable cGMP regulations and SOPs, and supports regulatory audits.

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.
• Previous experience in gene therapy is preferred.
• An equivalent combination of education and experience is acceptable.

Skills

• Strong good documentation practices.
• Strong technical writing skills.
• Excellent verbal and written communication skills, detail-oriented personality.
• Experience training and/or mentoring laboratory analysts preferred.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

Work Environment

• Primarily a laboratory setting.
• May involve standing, sitting, and using laboratory equipment for extended periods.
• Some lifting of equipment or materials may be required.
• Work may involve exposure to chemicals or biological materials.

Benefits

• 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!