Oruka Therapeutics
Biotech
BiosampleOperationsAssociate/Sr.Associate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Biosample Operations Associate/Sr. Associate at Oruka Therapeutics. Skills: Biosample lifecycle management, Laboratory vendor management, Data reconciliation. Coordinate biospecimen management activities. Monitor sample collection”
Industry & Context.
Problem-solving; Issue resolution
What They're Looking For.
Must Have
Proficiency with Microsoft Office, Clinical trial management systems experience, Laboratory tracking systems experience, Sample tracking systems experience, Analytical capabilities, Problem-solving capabilities, Issue-resolution capabilities
Nice to Have
Biomarker sample programs experience, PK sample programs experience, PD sample programs experience, Immunogenicity sample programs experience, Genomic sample programs experience, Translational medicine sample programs experience, Biotechnology company experience, Pharmaceutical company experience, Emerging biotech experience, Central laboratory data portals familiarity, Sample inventory systems familiarity, Laboratory information management systems familiarity, Clinical studies support experience
What You'll Do.
Coordinate biospecimen management activities
Monitor sample collection
Monitor sample shipment
Monitor sample receipt
Monitor sample processing
Monitor sample storage
Monitor sample transfer
Ensure chain-of-custody documentation
Track sample inventories
Reconcile sample records
Support sample tracking tools development
Support sample tracking tools maintenance
Support biosample management plans development
Support biosample management plans maintenance
Serve as operational contact
Coordinate sample transfers
Review laboratory documentation
Review sample transfer records
Review inventory reports
Escalate sample discrepancies
Assist resolving sample discrepancies
Support laboratory vendor oversight
Perform data reconciliation
Investigate sample discrepancies
Document sample discrepancies
Support corrective actions
Support preventive actions
Maintain biosample metrics
Generate study status reports
Support inspection readiness
Support audit readiness
Partner with Clinical Operations
Partner with Clinical Development
Partner with Translational Medicine
Partner with Biometrics
Partner with Data Management
Partner with Regulatory Affairs
Support study startup activities
Review laboratory manuals
Review sample collection procedures
Review laboratory specifications
Review sample flow requirements
Review study protocols
Review schedules of assessments
How You'll Work.
Team & Collaboration
Internal and external stakeholders; Investigative sites; Central laboratories; Specialty laboratories; Clinical operations; Study vendors; Cross-functional teams
Communication Scope
Stakeholder management
Full Job Description
About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Biosample Operations Associate/Senior Associate Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required. Role Overview: The Biosample Operations Associate/Senior Associate is responsible for supporting the operational management of clinical trial biospecimens throughout the sample lifecycle. This role serves as the primary liaison between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors to ensure the accurate tracking, transfer, reconciliation, and documentation of clinical trial samples. The Biosample Operations Associate/Senior Associate oversees chain-of-custody processes and sample logistics from collection at clinical sites through shipment to central laboratories and onward transfer to specialty or third-party testing laboratories. This position does not involve direct handling of biological specimens but requires close collaboration with internal an
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