Biosample Operations Associate/Sr. Associate

<div class="content-intro"><p><strong>About Us:</strong><strong>&nbsp;</strong></p> <p>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 <a href="http://www.orukatx.com">www.orukatx.com</a></p> <p>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.&nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. &nbsp;</p></div><h1><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Job Title: Biosample Operations Associate/Senior Associate</span></h1> <p><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><strong>Location:&nbsp;</strong>Remote or Hybrid 3 days/week if located near office in W<em>altham, MA or Menlo Park, CA</em> will be required.</span></p> <h2><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Role Overview:</span></h2> <p><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">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.</span><br><br><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">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 and external stakeholders to ensure sample integrity, regulatory compliance, and data quality.</span><br><br><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">As a member of a growing biotechnology company, this individual will play a key role in building, optimizing, and scaling biosample operational processes. The ideal candidate is comfortable working in a dynamic environment, identifying process improvements, and helping establish best practices that support an expanding clinical development portfolio.</span></p> <h2><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Key Responsibilities:</span></h2> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Biosample Lifecycle Management</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Coordinate and oversee biospecimen management activities across clinical studies.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Monitor sample collection, shipment, receipt, processing, storage, and transfer activities performed by external laboratory vendors.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Ensure complete and accurate chain-of-custody documentation throughout the sample lifecycle.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Track sample inventories and reconcile sample records between investigative sites, central laboratories, specialty laboratories, and sponsor tracking systems.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Support the development and maintenance of sample tracking tools, reports, and study-specific biosample management plans.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Laboratory and Vendor Management</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Serve as the primary operational contact for central laboratories and specialty testing laboratories regarding biosample logistics and study requirements.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Coordinate sample transfers between laboratories to support biomarker, PK, PD, immunogenicity, genomic, and exploratory research testing.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Review laboratory documentation, sample transfer records, and inventory reports for completeness and accuracy.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Escalate and assist in resolving sample discrepancies, missing samples, shipment delays, temperature excursions, and chain-of-custody issues.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Support oversight of laboratory vendors to ensure compliance with study requirements and timelines.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Data Reconciliation and Quality Oversight</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Perform routine reconciliation of biosample data across laboratory databases, EDC systems, IRT systems, and sponsor tracking tools.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Investigate and document sample-related discrepancies and support corrective and preventive actions when necessary.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Maintain biosample metrics and generate study status reports for cross-functional stakeholders.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Support inspection and audit readiness by ensuring complete and accurate biosample documentation and records.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Cross-Functional Collaboration and Process Development</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Partner closely with Clinical Operations, Clinical Development, Translational Medicine, Biometrics, Data Management, Regulatory Affairs, and external vendors.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Support study startup activities, including review of laboratory manuals, sample collection procedures, laboratory specifications, and sample flow requirements.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Review study protocols and schedules of assessments to ensure biosample collection and testing requirements are operationally feasible and clearly defined.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Contribute to the development, implementation, and continuous improvement of biosample management processes, tools, and SOPs.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Identify operational efficiencies and recommend process enhancements to improve sample visibility, data quality, and vendor performance.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Help establish scalable biosample operations infrastructure to support the company’s growing clinical development programs.</span></li> </ul> <h2><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Qualifications:</span></h2> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Education</span></h3> <p><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline required.</span></p> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">2–5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related field.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors preferred.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Understanding of clinical trial biosample management processes, chain-of-custody requirements, and laboratory operations.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience with sample reconciliation, logistics coordination, and vendor management preferred.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Knowledge and Skills</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Working knowledge of ICH-GCP guidelines and clinical trial operational requirements.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Understanding of biospecimen collection, processing, storage, shipment, and tracking workflows.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong organizational skills with exceptional attention to detail and documentation accuracy.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Ability to manage multiple studies and priorities in a fast-paced biotech environment.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Demonstrated ability to work independently and help build processes in a growing organization.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Excellent communication and stakeholder management skills.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Proficiency with Microsoft Office applications and clinical trial management, laboratory, or sample tracking systems.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Strong analytical, problem-solving, and issue-resolution capabilities.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Preferred Qualifications</span></h3> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience in a biotechnology or pharmaceutical company environment, particularly within a small or emerging biotech.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Familiarity with central laboratory data portals, sample inventory systems, and laboratory information management systems (LIMS).</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">Experience supporting clinical studies from startup through study closeout.</span></li> </ul> <p><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><strong>Compensation:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.</span></li> <li style="font-size: 12pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;">The anticipated salary range for Associate level is $104,000 - $125,000.&nbsp; The anticipated salary range for Sr. Associate level is $130,000 - $146,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary Range For the Role</div><div class="pay-range"><span>$104,000</span><span class="divider">&mdash;</span><span>$146,000 USD</span></div></div></div><div class="content-conclusion"><p><strong>What We Offer:</strong></p> <ul> <li>A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.</li> <li>Competitive salary and benefits package.</li> <li>A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.</li> <li>Opportunities for professional growth and development.</li> </ul></div>