Senior Scientist, Analytical Sciences

Role Summary

Korro Bio seeks an analytical scientist to join the growing CMC team. The role focuses on managing CMO analytical labs and developing analytical methods, characterizing impurities and degradation pathways, and transferring, qualifying, and validating analytical methods for RNA-based therapies. The position supports the quality and stability of drug substances and drug products throughout the development lifecycle and collaborates with cross-functional teams and external partners to ensure analytical data meets regulatory filings and clinical trial needs.

Responsibilities

• Serve as SME for RNA-based drug substance and drug product release and characterization assays, including developing and optimizing analytical methods as needed.
• Support analytical method validation, transfer, and troubleshooting to ensure compliance with cGMP standards.
• Collaborate with Process Development teams to integrate analytical methods into DS and DP manufacturing workflows.
• Analyze, interpret, and present complex data to cross-functional teams and senior management.
• Author and review technical reports, protocols, SOPs, and sections of regulatory filings (IND, IMPD, etc.).
• Assist in managing external analytical collaborations with CROs and CMOs, ensuring data quality and on-time delivery.
• Stay current with emerging analytical technologies and apply innovative solutions to improve method robustness and efficiency.
• Support investigations and root cause analyses for any OOS results, deviations, or process failures.

Qualifications

• Required: PhD in Analytical Chemistry, Biochemistry, Molecular Biology, or related field with 2+ years of experience; or MS with 7+ years or BS with 9+ years of relevant industry experience.
• Required: 3+ years of hands-on experience in analytical method development for biologics, with experience in RNA therapeutics preferred.
• Required: Expertise in chromatographic (e.g., UPLC-UV, UPLC-MS) and spectroscopic (e.g., UV-Vis) techniques, with a strong understanding of method validation requirements.
• Required: Familiarity with cGMP and ICH guidelines for analytical development and quality control of small molecules and/or biologics.
• Required: Experience with designing and managing stability studies, impurity profiling, and degradation pathways.
• Required: Expertise in managing primary and working reference standard qualification, aliquoting, and long-term management across end users.
• Required: Experience with transfer, qualification, and ideally validation of methods.
• Required: Experience supporting batch disposition, OOS, OOT, and investigations.
• Required: Excellent written and verbal communication skills, with experience drafting technical reports and regulatory documents.
• Required: Ability to work collaboratively in a fast-paced environment and manage multiple projects simultaneously.
• Preferred: Experience in RNA therapeutics.