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Director, Analytical Development presso Korrobio

Korrobio · 60 First St, Stati Uniti d'America · Hybrid

$214,667.00  -  $250,000.00

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Description

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.

Position Summary: 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.   

Key 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.

    • Required Qualifications:

  • 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. 

    • Additional Information

    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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