Analyst II/Senior Analyst, Quality Control

Kriya Therapeutics, Inc.; United States; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Flexible Time Off

Medical Insurance

401(k) with Company Match

EAP

Job summary

Kriya Therapeutics, Inc. is seeking a Quality Control professional to perform and oversee cGMP testing on production materials, intermediates, and final products at our RTP, NC site.

The role includes authoring SOPs and supporting QC operations, with the level aligned to experience as Analyst II or Senior Analyst. Ideal candidates have a chemistry-related degree, 3+ years in QC, experience with HPLC/PCR, and strong documentation skills, with gene therapy exposure preferred.

Qualifications

• BS/Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, or related field.
• 3+ years in a cGMP, QC, or similar lab environment; 4+ years for Senior Analyst.
• Experience performing HPLC, PCR, or cell-based potency testing.
• Gene therapy experience preferred.
• Strong documentation practices.
• Technical writing skills.
• Excellent verbal and written communication; detail-oriented.
• Experience mentoring lab analysts preferred.
• Self-directed in fast-paced settings.

Responsibilities

• Perform routine and non-routine cGMP testing for samples and train/mentor lab personnel as needed.
• Lead, develop, and execute QC methods across HPLC, CE, PCR, and cell-based potency.
• Verify and review QC data.
• Lead project work, deviations, investigations, CAPAs, and continuous improvement.
• Serve as SME for assays, instruments, and equipment.
• Support equipment maintenance, calibration, alarms, and sample handling.
• Participate in GMP validation of lab equipment and IQ/OQ/PQ testing onboarding.
• Ensure lab compliance with cGMP regulations and SOPs; support regulatory audits.

Skills

HPLC

PCR

Cell-based potency testing

Documentation practices

Technical writing

Verbal & written communication

Mentoring/training

Self-directed work style

Education

BS in Chemistry/Biochemistry/Biology

Tools

Laboratory instruments

Job description

Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

Department

Quality Control

Employment Type

Full Time

Location

Research Triangle Park, NC

Description

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

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.

Key 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.

Experience & Skills

Experience & Skills and Work Environment

• 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.
• Strong good documentation practices.
• Strong technical writing skills.
• Excellent verbal and written communication skills, detailed-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.

Life at Kriya

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. We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & 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!