Principal Scientist, Analytical Sciences

Orro; Cambridge (MA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Flexible spending account

Health savings account

Free parking

Job summary

Korro is seeking an experienced Analytical Scientist to join the CMC team in Cambridge, Massachusetts. The role focuses on developing and managing analytical methods critical for oligonucleotide-based therapies, ensuring compliance with regulatory standards and supporting drug development timelines.

The ideal candidate will have a PhD in Chemistry or related fields, with a strong background in analytical method development, cGMP standards, and excellent communication skills. Korro offers competitive compensation and a comprehensive benefits package.

Qualifications

• 3+ years of experience in analytical method development for small molecule therapeutics.
• Strong understanding of cGMP and ICH guidelines for analytical aspects.
• Expertise in managing primary and working reference standard qualification.

Responsibilities

• Develop and optimize analytical methods for drug substances.
• Support analytical method validation and compliance.
• Collaborate with cross-functional teams on analytical methods.

Skills

Analytical method development

Chromatographic techniques

Spectroscopic techniques

cGMP compliance

Technical report writing

Collaboration

Education

PhD in Analytical or Organic Chemistry

MS with 7+ years experience

BS with 10+ years experience

Job description

Korro Bio is seeking an experienced analytical scientist to join the growing CMC team. The role focuses on managing CMO analytical labs, developing analytical methods, characterizing impurities and degradation pathways, and transferring, qualifying, and validating analytical methods for synthetic oligonucleotide-based therapies. The position supports the quality and stability of drug substances and drug products throughout the development lifecycle, working closely with cross‑functional teams and external partners to ensure 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, 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.
• Working 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.

Salary: $160,000 - $190,000 a year.

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, dependent care flexible spending account, a Company‑funded health savings account, and free parking.