Lead analytical strategy for synthetic oligonucleotide drug substance and product: develop, transfer, qualify/validate analytical methods (LC-UV, LC-MS, HRMS, UV-Vis), manage CMO/CRO analytical activities, support stability and impurity characterization, author regulatory documentation, and lead investigations/OOS resolution to support clinical and regulatory progress.
Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts.
We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
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.
Key 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.
Required Qualifications:
- 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.
Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
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