Biosample Operations Associate/Sr. Associate

About the Company

Oruka Therapeutics is a biotechnology company developing next-generation biologics for chronic skin diseases. Its focus is on helping patients with conditions such as plaque psoriasis achieve deep and durable disease control, with treatment potentially needed only once or twice a year. The company is advancing a proprietary antibody portfolio designed to address the key biological pathways involved in plaque psoriasis and other inflammatory and dermatologic conditions.

As the organization expands, it is looking for people who want more than a standard role and are excited to help shape a collaborative, inclusive, and positive workplace culture.

Role Summary

The Biosample Operations Associate/Senior Associate supports the day-to-day management of clinical trial biospecimens across the full sample lifecycle. This position acts as the main operational point of contact for investigative sites, central labs, specialty testing labs, clinical operations, and study vendors to make sure samples are tracked, transferred, reconciled, and documented correctly.

The role also owns chain-of-custody oversight and biosample logistics from site collection to central lab shipment and onward transfer to specialty or third-party testing partners. It does not require direct handling of specimens, but it does require strong coordination with internal and external teams to protect sample integrity, maintain compliance, and support high-quality data.

Because the company is growing, this position will also contribute to building and improving biosample workflows, tools, and best practices that can scale with the clinical portfolio.

Work Location

This role can be remote. A hybrid arrangement of three days per week in the office is expected for candidates based near the Waltham, MA or Menlo Park, CA office locations.

Key Responsibilities

• Oversee biospecimen operations across clinical studies from collection through transfer and reconciliation.
• Track collection, shipment, receipt, processing, storage, and transfer activities carried out by external laboratory vendors.
• Maintain complete chain-of-custody records throughout the sample journey.
• Reconcile sample inventories and resolve differences between clinical sites, laboratories, and sponsor tracking systems.
• Help maintain sample tracking tools, study reports, and biosample management plans tailored to each study.
• Act as the day-to-day operational contact for central and specialty laboratories on sample logistics and study-specific needs.
• Coordinate sample movement between labs to support biomarker, PK, PD, immunogenicity, genomic, and exploratory testing.
• Check laboratory documents, transfer records, and inventory reports for completeness and accuracy.
• Escalate and help resolve lost samples, discrepancies, shipment delays, temperature excursions, and custody issues.
• Support vendor oversight to ensure study timelines and requirements are met.
• Reconcile biosample data across lab databases, EDC, IRT, and sponsor systems on a routine basis.
• Investigate sample-related issues and support corrective and preventive actions when needed.
• Maintain biosample metrics and prepare study status updates for cross-functional partners.
• Support inspection readiness and audit preparedness through accurate records and documentation.
• Work with Clinical Operations, Clinical Development, Translational Medicine, Biometrics, Data Management, Regulatory Affairs, and external vendors.
• Support study start-up by reviewing lab manuals, collection procedures, lab specifications, and sample flow requirements.
• Review protocols and schedules of assessments to confirm that sample collection and testing plans are operationally workable and clearly written.
• Help create, implement, and improve biosample processes, tools, and SOPs.
• Recommend practical efficiency improvements that increase visibility, data quality, and vendor performance.
• Contribute to building scalable biosample operations infrastructure for a growing clinical development organization.

Qualifications

A bachelor’s degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a similar scientific field is required.

Ideal candidates bring 2 to 5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related discipline. Background working with central labs, specialty testing labs, CROs, or clinical trial vendors is preferred. Familiarity with biospecimen workflows, chain-of-custody requirements, laboratory operations, sample reconciliation, logistics coordination, and vendor management is also preferred.

Strong candidates will have working knowledge of ICH-GCP and clinical trial operational expectations, along with a clear understanding of biospecimen collection, processing, storage, shipping, and tracking workflows. The role also calls for excellent organization, sharp attention to detail, and accurate documentation.

The position requires the ability to juggle multiple studies and priorities in a fast-moving biotech environment, work independently, and help establish processes in a growing company. Strong communication, stakeholder management, analytical thinking, problem-solving, and issue-resolution skills are important, as is proficiency with Microsoft Office and clinical trial management, laboratory, or sample tracking systems.

Preferred Background

Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs is a plus. Prior work in biotechnology or pharmaceuticals, especially in a smaller or emerging company, is also preferred. Familiarity with central laboratory portals, sample inventory tools, and laboratory information management systems (LIMS) would be advantageous. Experience supporting studies from startup through closeout is another strong plus.

Compensation

The role includes a competitive base salary, equity, and a performance-based bonus opportunity. For Associate level, the expected salary range is $104,000 to $125,000. For Sr. Associate level, the expected salary range is $130,000 to $146,000. The final offer will depend on several factors, including the candidate’s relevant experience, industry background, and education. Because the company operates across multiple states, compensation may vary for roles based in other locations.

The stated total salary range for this role is $104,000 USD to $146,000 USD.

What the Company Offers

• An opportunity to work in a startup environment where your efforts can directly support the delivery of new medicines to patients.
• A competitive pay and benefits package.
• A welcoming and inclusive team culture that encourages authenticity at work.
• Professional growth and development opportunities.

Additional Information

This position is part of a growing organization that values candidates who can help shape systems, improve operations, and contribute to the company’s long-term mission.