Oruka Therapeutics

Biotech

BiosampleOperationsAssociate/Sr.Associate

$104–146k Waltham, Massachusetts, United States; Menlo Park, California, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Biotech
Problems you'll solve

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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