Senior Technical Specialist

CellCarta • Lake Forest, CA

9d • Onsite

About The Position

The Senior Technical Specialist supports assay operations, laboratory processes, technical training, and equipment maintenance to ensure high-quality and compliant laboratory activities. This role serves as a technical resource for internal teams, assists with assay troubleshooting and validation, and supports project execution, audits, and continuous process improvement.

Requirements

• Candidates must meet CLIA personnel requirements to perform moderate- or high-complexity clinical sample testing or inclusion criteria testing for clinical trials
• Experience with the Ventana Benchmark, Leica Bond Rx, and Dako Autostainer Link 48 platforms is preferred.
• Experience with the Dako Omnis platform is a plus
• Knowledge of GCP, GCLP, and GLP
• Good communication skills
• Ability to read and interpret documents such as protocols, safety rules, and procedure manuals written in English, and to record results in English
• Ability to solve practical problems and interpret a variety of instructions provided in written, oral, or schedule form

Responsibilities

• Assist with coordinating and scheduling assay runs, and monitor the completion status of assigned projects
• Support activities for optimization and validation of histochemistry, immunohistochemistry, in situ hybridization, immunofluorescence, and other laboratory-developed assays
• Assist in technical training, staff education, and competency assessments. Develop and maintain training documentation, bench training forms, training guides, and troubleshooting reference materials, and ensure appropriate training of laboratory staff through instruction and hands-on demonstrations
• Assist with troubleshooting, validation, qualification, and preventive maintenance of laboratory equipment. Communicate with vendors as needed and ensure maintenance documentation is completed in a timely manner
• Assist with client calls and/or audits as a SME, as needed/applicable, and serve as an internal technical resource for project managers and other internal teams
• Assist in maintenance and inventory of the tissue bank and tissue sample procurement
• Initiate and QC new specification worksheets and autostainer protocols
• Assist with tracking and managing all staining protocols and versions
• Coordinate and assist with assay transfer across CellCarta laboratories
• Provide feedback to management regarding challenges relating to laboratory operations and assay development
• Monitor the schedule for and completion of equipment preventive maintenance and other recurring events required for regulatory compliance
• Prepare and QC reagents and solutions according to SOPs or approved written instructions
• Perform histochemical and immunohistochemical staining according to SOPs and protocols
• Perform in situ hybridization according to SOPs and protocols
• Perform clinical, non-clinical, and internal research projects approved by management or the Medical Director
• Maintain detailed and accurate records of all assays and results
• Perform other duties as assigned by management

Benefits

• Medical, dental, and vision benefits
• 401(k) retirement savings plan with a healthy match
• Vacation and sick time
• Employee Assistance Program (EAP)
• Referral Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior