Specialist I​/II, 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.

Department: Quality Control

Location: Research Triangle Park, NC

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 Bio Space’s “2025 Best Places to Work.”

The Specialist I/II, Quality Control is responsible for the technical ownership of all PCR based assays, including method validation/transfer, standard and critical reagent qualification/release, out of specification and deviation ownership, and troubleshooting of technical issues that arise within the laboratory. They are expected to set a positive example for junior QC contributors and provide support to other areas, where necessary.

• Responsible for the authoring of SOPs, validation/transfer protocols and reports, critical reagent qualifications, investigations, and regulatory support documentation for all PCR based assays.
• Performs non‑routine cGMP testing and coordinates with the laboratory manager for testing in support of all owned protocols and investigations and occasionally supports routine cGMP testing where necessary.
• Verifies and reviews QC data.
• Serves as SME for PCR based assays / instruments / equipment.
• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, and sample handling/tracking).
• Provide additional technical support for other areas, including cell‑based potency, ELISA, HPLC, CE, and other analytical techniques, where required.
• Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits.

• BS degree in Chemistry, Microbiology, Biological Sciences, or related field.
• Advanced degree preferred.
• 5+ years of relevant experience.
• An equivalent combination of education and experience is acceptable.
• Must have experience performing PCR based testing, with ddPCR preferred.
• Must have experience owning or executing method qualification, validation, or transfers.
• Experience in developing materials and training QC Analysts in quality principles, procedures and analytical methods/equipment.
• Hands‑on experience with other analytical testing procedures in a GMP or GLP environment is preferred.
• Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations.
• Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes.
• Excellent and effective written, verbal communication and presentation skills.

• Primarily in an office or laboratory setting.
• May involve standing, sitting, and using laboratory equipment for extended periods.
• Some lifting of equipment or materials may be required.

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.

• 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

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job‑related assignments as requested.