Jobs at Kriya Therapeutics, Inc.

Provides Quality Assurance support for clinical labeling, batch record review, raw material release, deviations, CAPAs, change controls, SOPs, risk assessments, and manufacturing operations. Supports site startup activities, including electronic batch record implementation, material onboarding, and drug substance/product projects. Requires cross-functional collaboration, cleanroom gowning, and occasional support outside normal business hours.

Provide scientific leadership across clinical study lifecycle including protocol and regulatory document development, study design support, data review and analysis, vendor and investigator selection oversight, training, and preparation of abstracts, manuscripts, and clinical study reports to ensure scientific quality and compliance.

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.