
Director, Analytical Development
Korro Bio, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $214,667 - $250,000 per year
Job Level
About the role
- leading for all aspects of analytical development related to both drug substance and drug product components of the modalities
- responsible for the deployment of methods for routine analysis of oligonucleotides to advance our RNA editing drug discovery platform and programs
- play a key role in advancing a pipeline of products from the early stage drug development to market approval
- require leadership across a matrixed analytical organization, effective collaboration with other CMC functions, close management of CDMO activities, and significant contribution to the overall CMC strategy for the program
- Deep knowledge of cGMPs and regulatory guidelines, significant experience in the CMC development of oligonucleotide and considerable expertise in the analytical techniques and strategies commonly used in the development of oligonucleotides is essential.
- express a high attention to details, be comfortable multitasking in a fast-paced startup environment
Requirements
- Ph.D. in Analytical Chemistry or related discipline, with 8+ years or M.Sc. in Analytical Chemistry or related discipline, with at least 12+ years of analytical development experience of clinical development of oligonucleotide in pharma or biotech.
- Minimum of 5 years direct leadership experience of managing internal and external teams.
- Direct experience in oligonucleotide method development of ASO and siRNA (both conjugated and unconjugated), with expertise in methods, including Mass Spectrometry of complex molecules, UPLC (IP-RP, IEX, HILIC), sequencing, Karl-Fischer, SEC, UV-Vis, FT-IR, GC, NMR, and DSC.
- Experience representing analytical development on cross functional CMC project teams.
- Knowledge and experience with cGMPs and regulatory guidelines, in particular oligonucleotides and conjugated therapeutics is required.
- Excellent interpersonal skills, ability to effectively communicate and collaborate both verbally and in written communications.
- Detail-oriented, excellent problem-solving abilities, commitment to high quality.
- Exemplary organizational skills, self-motivated, curious, collaborative, and able to consistently maintain timelines for assigned activities.
Benefits
- competitive compensation, including equity-based compensation
- 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
- free parking
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical developmentoligonucleotide method developmentMass SpectrometryUPLCsequencingKarl-FischerSECUV-VisFT-IRNMR
Soft skills
leadershipeffective collaborationattention to detailmultitaskingproblem-solvingcommunicationorganizational skillsself-motivatedcurious
Certifications
Ph.D. in Analytical ChemistryM.Sc. in Analytical Chemistry