Principal Scientist, Analytical Sciences

Korro Bio•Cambridge, MA

1d•$160,000 - $190,000•Onsite

About The Position

Korro Bio is seeking an experienced analytical scientist to join the growing CMC team. You will focus on management of CMO analytical labs as well as development of analytical methods, characterization of impurities, degradation pathways, and transfer, qualification/validation of analytical methods for synthetic oligonucleotide-based therapies. This role will support and manage - the quality and stability of drug substances and drug products throughout the development lifecycle. You will work closely with cross-functional teams and external partners to ensure that analytical data supports regulatory filings and clinical trial progression.

Requirements

PhD in Analytical, Organic Chemistry, or related field with 3+ years’ experience; or MS with 7+ years or BS with 10+ years of relevant industry experience.
3+ years of hands-on experience in analytical method development for small molecule therapeutics. Experience in synthetic oligonucleotide therapeutics is desired.
Expertise in chromatographic (e.g., LC -UV, and LC-MS) and spectroscopic techniques (e.g., UV-Vis), with a strong understanding of method validation requirements.
Experience with compendial methods used to release sterile products and compendial method verification.
Familiarity with HRMS analysis in the identification of DS impurities.
Functioning knowledge of the chemical principles of molecular degradation pathways.
Strong understanding of cGMP and ICH guidelines for analytical aspects of small molecule sterile products in clinical development.
Experience with supporting design and management of stability studies
Expertise with managing primary and working reference standard qualification, aliquoting, and long-term management across all end users of the material.
Managed transfer, qualification, and ideally validation of methods.
Supported batch disposition, OOS, OOT, and investigations.
Excellent written and verbal communication skills, with experience drafting technical reports and regulatory documents.
Ability to work collaboratively in a fast-paced environment and manage multiple projects simultaneously.

Nice To Haves

Experience in synthetic oligonucleotide therapeutics is desired.

Responsibilities

Serve as SME for synthetic oligonucleotide-based drug substance and drug product release and characterization assays. Develop and optimize analytical methods as needed.
Support analytical method validation, transfer, and troubleshooting to ensure compliance with cGMP standards.
Collaborate with the Process/Formulation Development teams to ensure seamless integration of 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 timelines are met.
Stay current with emerging analytical technologies and apply innovative solutions to improve method robustness and efficiency.
Support investigations and root cause analyses for any out-of-specification (OOS) results, deviations, or process failures.