Director, Analytical Development jobs in United States
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Korro Bio, Inc. · 1 day ago

Director, Analytical Development

Korro Bio, Inc. is a biopharmaceutical company focused on developing a new class of genetic medicines using its proprietary RNA editing platform. The Director of Analytical Development will lead all aspects of analytical development related to drug substance and drug product components, ensuring effective collaboration across CMC functions and advancing products from early-stage development to market approval.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Oligonucleotide therapeuticsAnalytical method developmentCGMP knowledgeMass SpectrometryRegulatory guidelinesLeadership experienceInterpersonal skillsProblem-solving abilitiesOrganizational skillsCollaboration skills

Required

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

Equity-based compensation
Medical
Dental
Vision
401(k) retirement plan
Life insurance
A dependent care flexible spending account
A Company-funded health savings account
Free parking

Company

Korro Bio, Inc.

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Korro Bio was founded to turn extraordinary scientific insights into life-altering new treatments for patients.

H1B Sponsorship

Korro Bio, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)

Funding

Current Stage
Public Company
Total Funding
$277.5M
Key Investors
Deep Track CapitalEventideWu Capital
2024-04-18Post Ipo Equity· $70M
2023-11-06IPO
2022-01-05Series B· $116M

Leadership Team

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Ram Aiyar
Chief Executive Officer
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Todd Chappell
Chief Operating Officer
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Company data provided by crunchbase