Clinical LC-MS/MS Mass Spectrometry Operations Lead

BioLegend, Inc.; Pittsburgh (Allegheny County); On-site; USD 75,000 - 91,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Life and Disability Insurance

Paid Time-Off

Parental Benefits

Compassionate Care Leave

401k with Company Match

Employee Stock Purchase Plan

Job summary

BioLegend, Inc. is seeking a Scientific Program Lead, Mass Spectrometry Operations to bridge R&D and clinical mass spectrometry. You will guide assay transfer, validate and implement workflows, and optimize operations for new testing services.

You will partner with R&D, quality, regulatory, and project management to enable technology transfer, assay deployment, and continuous improvement, with growth toward broader laboratory leadership in mass spectrometry.

Qualifications

• PhD in Biochemistry or STEM related discipline.
• Experience with LC-MS/MS assay development, optimization, validation, or implementation.
• Strong technical writing experience including SOPs, validation reports, protocols, and scientific documentation.
• Experience working in a regulated laboratory environment.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead transfer of LC-MS/MS assays from R&D into clinical laboratory operations.
• Coordinate assay feasibility, optimization, validation, and implementation activities.
• Convert research methodologies into scalable and robust clinical workflows.
• Develop and review validation protocols, reports, SOPs, and technical documentation.
• Support launch readiness activities for new mass spectrometry assays.
• Provide scientific support for routine LC-MS/MS testing operations.
• Monitor assay performance, quality metrics, and instrument performance trends.
• Assist with troubleshooting analytical, instrumentation, and workflow challenges.
• Collaborate with laboratory personnel to improve efficiency, quality, and turnaround times.
• Support maintenance and optimization of LC-MS/MS instrumentation and associated workflows.
• Partner with Quality and Regulatory teams to ensure compliance with CLIA, CAP, NYSDOH, and other applicable requirements.
• Support investigations, corrective actions, proficiency testing, and quality improvement initiatives.
• Participate in QC data review and ongoing assay performance monitoring.
• Serve as a technical resource for clinical laboratory personnel.
• Assist with training and onboarding of new staff.
• Coordinate cross-functional project activities and communicate progress to leadership.
• Contribute to long-term planning for expansion of Mass Spectrometry capabilities and test menu growth.
• Develop operational leadership skills with the expectation of assuming increasing management responsibilities over time.

Skills

LC-MS/MS knowledge

Technical writing

Cross-functional collaboration

Regulated laboratory experience

Education

PhD in Biochemistry or STEM related discipline

Tools

Triple quadrupole MS platforms

Regulatory requirements (CLIA, CAP, NYSDOH)

Job description

BioLegend, Inc. is seeking a Scientific Program Lead, Mass Spectrometry Operations to bridge R&D and clinical mass spectrometry. You will guide assay transfer, validate and implement workflows, and optimize operations for new testing services.

You will partner with R&D, quality, regulatory, and project management to enable technology transfer, assay deployment, and continuous improvement, with growth toward broader laboratory leadership in mass spectrometry.