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Hybrid Associate Director/Director, Analytical Development and Validation, Tech Ops – Biologics
Posted 3 days ago
About the role
- Leading analytical development and validation for biologics at Oruka Therapeutics. Requires expertise in method validation and regulatory submissions for monoclonal antibodies.
Responsibilities
- Lead late-stage analytical development activities for biologics, including method validation, method qualification, and method transfer 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
- 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
- Manage and provide technical oversight to CDMOs and contract
- Review and approve protocols, validation reports, development reports, and regulatory
Requirements
- Experience with monoclonal antibodies and PFS/Auto Injectors is a
- Associate Director: Master’s (7+ years) or PhD (5+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
- 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
- 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
- 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
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
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