Clinical R&D Mass Spec Specialist
About The Position
The Scientific Program Lead, Mass Spectrometry Operations serves as the primary liaison between Research & Development and the Clinical Mass Spectrometry Laboratory. The role transitions assays from development into regulated clinical testing, supports validation and implementation, optimizes workflows, and ensures operational readiness for new testing services. The position partners with R&D scientists, laboratory operations, quality, regulatory affairs, and project management teams to facilitate technology transfer, assay deployment, and continuous improvement. It is intended to develop into a laboratory leadership role with increasing responsibility for mass spectrometry operations, personnel, quality systems, and strategic growth initiatives.
Requirements
- PhD in Biochemistry or a 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.
Nice To Haves
- Experience supporting clinical laboratory operations.
- Familiarity with CLSI guidelines and assay validation requirements.
- Experience with triple quadrupole mass spectrometry platforms.
- Knowledge of quality systems, CAP, CLIA, and New York State regulatory requirements.
- Experience leading projects across multiple departments.
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.
Benefits
- Medical, dental, and vision insurance options
- Life and disability insurance
- Paid time-off
- Parental benefits
- Compassionate care leave
- 401k with company match
- Employee stock purchase plan
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
