Director, Analytical Development

Korro Bio • Cambridge, MA

10h

About The Position

Korro Bio is seeking a passionate, self-motivated, and talented leader with a background in oligonucleotide therapeutics to join our Analytical Development team within CMC function. In this key role, you will be leading for all aspects of analytical development related to both drug substance and drug product components of the modalities. The successful candidate will be responsible for the deployment of methods for routine analysis of oligonucleotides to advance our RNA editing drug discovery platform and programs. The successful candidate will play a key role in advancing a pipeline of products from the early stage drug development to market approval. Success will 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. Candidate must 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.

Responsibilities

• Establishes phase-appropriate analytical control strategies for drug substance and drug product development, including specifications and retest/expiry assignments.
• Leads method development, qualification, validation, release, and stability testing of drug substance and drug product for oligonucleotide, especially LC/MS, for routine characterization, profiling, and quantitation of oligonucleotides, their impurities, and raw materials across all stages of clinical development.
• Collaborate with all CMC functions such as Process Chemistry, Formulation Development, Quality, Regulatory and CMC leadership to develop strategies and deliver on key objectives.
• Lead and manage timelines and analytical development both in-house and externally at CDMO/CRO, including tech transfer process, ensuring adherence to global regulations and SOPs.
• Lead troubleshooting, improvement, and life-cycle management of analytical instruments (mainly HPLC-LC/MS)
• Author, review and approve documentation including technical reports, SOPs, test methods, and release specifications and where possible analytical CMC sections of regulatory filings.
• Identify, evaluate, and procure analytical equipment and reagents to enhance the capabilities of the department.
• Supervise and train colleagues in the Analytical Development team on the correct use of equipment, analytical methods for process testing.
• Serve as a role model for junior scientists, and a champion for scientific rigor within an open, supportive, and data-driven environment.
• Discuss and communicate scientific results at internal and external meetings and research boards as a core team member of matrix project teams.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees