The Role
Perform routine and non-routine cGMP QC testing (HPLC, CE, PCR, cell-based potency), author SOPs/protocols/reports, verify and review QC data, lead investigations/CAPAs, support equipment maintenance and IQ/OQ/PQ validation, and ensure lab compliance for regulatory audits.
Summary Generated by Built In
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.”
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
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 and Work Environment
Experience & Skills
- 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
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!
About
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Skills Required
- Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, or related field
- 3+ years experience in a cGMP, QC, or similar laboratory environment
- 4+ years experience preferred for consideration at the Senior Analyst level
- Hands-on experience performing HPLC, PCR, and cell-based potency testing
- Experience with capillary electrophoresis (CE) methods
- Strong good documentation practices and attention to detail
- Strong technical writing skills
- Excellent verbal and written communication skills
- Experience training and/or mentoring laboratory analysts
- Previous experience in gene therapy
- Experience participating in GMP validation activities (IQ/OQ/PQ)
- Self-directed with ability to work with limited direction in fast-paced environment
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The Company
What We Do
Kriya Therapeutics is a biopharmaceutical company dedicated to developing and manufacturing transformative, one-time gene therapies to address chronic diseases affecting millions of people worldwide. With operations in Research Triangle Park, North Carolina, and Silicon Valley, California, Kriya leverages an innovative platform for research, development, and manufacturing to revolutionize medicine and eliminate the burden of disease, aiming to make life-changing therapies accessible to all in need.
