Senior Scientist Technical Operations #4375

Responsibilities:- - Lead or assist in process troubleshooting activities, including root-cause analysis and impact assessments, resolving technical challenges. - Monitor process performance, analyze data and metrics, and contribute to process monitoring and improvement strategies to sustain high-quality, efficient operations. - Support the transfer and implementation of new assays and diagnostic products from development into production, ensuring robust performance across all workflow phases. - Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA, and other applicable standards. - Provide scientific and technical support to MSAT, Engineering Operations, and Clinical Lab teams. - Evaluate, qualify, and implement alternative reagents and vendors to maintain continuity and strengthen lab operations. - Identify process gaps and contribute to or lead process improvement initiatives to enhance efficiency, reliability, and quality. - Prepare comprehensive technical documentation, scientific reports, and regulatory submission materials as required. - Maintain high standards of scientific rigor, quality, and regulatory compliance in all process integration activities. - Lead complex investigations and root-cause analyses; implement effective CAPAs and preventive measures with clear verification of effectiveness. - Support lab readiness: training, tech transfer materials, troubleshooting guides, and operational playbooks for Clinical Lab teams. - Analyze complex datasets and present insights to technical and non-technical stakeholders to guide decisions. - Contribute to inspection/audit readiness and support interactions with CAP/CLIA, state agencies (e.g., NYS), and other regulatory bodies as needed. - These responsibilities summarize the roles primary responsibilities and are not an exhaustive list. They may change at the companys discretion. Required Qualifications:- - PhD in Life Sciences, Molecular Biology, Biochemistry, Bioengineering, or a related field. - Proven experience in technology transfer of assays and launching new products in a regulated diagnostic laboratory. - Direct, hands-on experience with end-to-end clinical workflows (pre-analytical, analytical, and post-analytical). - Strong knowledge of high-throughput laboratory automation and advanced instrumentation. - Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA. - Experience with or understanding of reagent manufacturing and alternative vendor qualification processes. - Experience participating in audits (internal, regulatory, or client-driven). - Excellent skills in technical documentation and scientific writing. - Demonstrated ability to collaborate effectively across MSAT, Engineering Operations, and Clinical Lab teams. - Six Sigma certification or significant experience with Lean, Kaizen, or other process improvement methodologies. - Hands-on experience with data analytics tools and platforms (e.g., JMP, Minitab, R, Python, Tableau) for process monitoring, analysis, and reporting. - Experience with laboratory information management systems (LIMS) or MES. - Advanced data analysis skills applied to laboratory operations and quality improvement. - Experience supporting laboratory scale-up, automation, or operational excellence projects.::: {qa=

Created: 2026-02-04