Senior Biosample Operations Manager

Job Title: Senior Biosample Operations Manager

Location: Hybrid - Waltham, MA -or- Menlo Park, CA Candidates will be required to be in-office 3 days/week.

Role Overview:

Oruka is seeking a Senior Biosample Operations Manager to manage the lifecycle of clinical samples, from patient to data. This position will be responsible for managing biosample collection, processing, shipment, tracking, storage, and analysis while ensuring compliance with clinical protocols, informed consent, regulatory requirements and ethical standards. The ideal candidate will work closely with cross-functional teams including Clinical Operations, Clinical Pharmacology, Translational Scientists, Program Management, and significant interaction with external vendors.

Key Responsibilities:

• Coordinate biosample logistics from clinical sites to central labs and subsequent analytical laboratories
• Manage query resolution and documentation
• Contribute to development of biosample management plans (BMPs), study protocols, ICFs, lab manuals and other relevant study documents
• Track individual subject permissions relative to informed consent
• Collaborate with Biomarker and Clinical teams and Biosample specimen vendors/laboratories to ensure sample and data delivery and support data analysis and interpretation
• Lead sample accounting and support reconciliation activities related to clinical samples
• Assist with process improvement activities for biosample operations including development of vLIMS (Laboratory Information management system) and biomarker data management systems to ensure traceability and accurate documentation
• Participate in study team meetings and provide updates on sample operational status
• Ensure compliance with clinical trial protocols, regulatory guidelines, and Good Clinical Practice (GCP)

Qualifications:

• Bachelor's degree in a life sciences discipline or related field
• Minimum of 5 years' experience in laboratory setting or sample management within the biotechnology or pharmaceutical industry
• Demonstrated understanding of ICH, GCP, and GLP guidelines
• Excellent organizational, interpersonal, and communication skills
• Strong proficiency with electronic data management systems (LIMS) and sample tracking software
• Proficiency with smartsheets
• Prior experience building LIMS system or equivalent infrastructure
• Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred
• Demonstrated ability to establish priorities, work independently and collaborate effectively with the cross-functional team and external partners/vendors
• Ability to work at least 3 days a week in Waltham, MA or Menlo Park , CA headquarters

Compensation:

• 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.
• The anticipated salary range for candidates, who will work in either Menlo Park, CA or Waltham, MA, is $$161,000 - $187,000. 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.

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.