Oruka Therapeutics · 2 months ago
Director, Analytical Development and Validation, Tech Ops (Biologics)
United States
Full-time
Remote
Director/Executive
$213K/yr - $240K/yr
10+ years expOruka Therapeutics is developing novel biologics to treat chronic skin diseases. The Director of Analytical Development and Validation will provide scientific leadership for late-stage analytical activities, focusing on method validation and lifecycle management of biologic drug products, particularly monoclonal antibodies.
BiotechnologyHealthcareHealth CareMedical
Responsibilities
Lead late-stage analytical development activities for biologics, including method transfer & validation for release, stability, characterization and device functional testing assays
Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods
Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing
Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s)
Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies
Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness
Support analytical risk assessments, control strategy development, and lifecycle management activities
Serve as analytical lead for regulatory interactions, including agency questions and inspections
Build, mentor, and lead a high-performing analytical development team (internal and/or external)
Set technical direction, priorities, and timelines for late-stage analytical deliverables
Manage and provide technical oversight to CDMOs and contract laboratories
Review and approve protocols, validation reports, development reports, and regulatory documentation
10-20% travel is required for this role
Qualification
Required
Experience with monoclonal antibodies and PFS/Auto Injectors is a requirement
Director: Master's (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC
Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics
Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO guidance
Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU
Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc
Experience with late-phase comparability studies, especially geared toward commercialization
Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch
Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
Must have a creative and strategic attitude with the ability to work in a fast-paced environment
Benefits
Equity
Performance-related bonus opportunity
Competitive salary and benefits package
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development
Company
Oruka Therapeutics
Oruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
Viking Global Investors
2026-04-28Post Ipo Equity· $700.35M
2025-09-17Post Ipo Equity· $180M
2024-09-03Post Ipo Equity· $275M
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