The University of Texas MD Anderson Cancer Center
Associate/Senior Scientist—Assay Development
The University of Texas MD Anderson Cancer Center, Boston, Massachusetts, us, 02298
Job Title: Associate/Senior Scientist—Assay Development
Job Number:
36660 Location:
Boston,MA Job Description A dynamic biotech company is looking for an
Associate or Senior Scientist in Assay Development
to join their on-site team. In this role, you’ll design, optimize, and validate bioanalytical assays that support a cutting-edge, highly automated clinical bioanalysis lab. You will work closely with teams in Automation, Quality, and Software to translate scientific needs into robust, scalable assays that run reliably on a technology-driven platform. This position offers the opportunity to work at the crossroads of biology, automation, and software, contributing directly to innovation in assay development. Responsibilities Develop, optimize, and troubleshoot plate-based immunoassays (e.g., ELISA, MSD/ECL), nucleic acid assays (qPCR, ddPCR), and cell-based/ligand-binding assays for PK, immunogenicity, and biomarker endpoints. Use DOE and statistical analyses to define sensitivity, limits of detection/quantification, precision, accuracy, specificity, linearity, robustness, and stability. Write and execute method development reports, validation plans, and reports compliant with ICH M10 and FDA bioanalytical guidance. Define control strategies, acceptance criteria, and system suitability; implement validated methods under GLP conditions with automation support. Collaborate with automation engineers to deploy assays on liquid handlers and robotic platforms, assisting with scripting, QC, and error handling. Work with software and data teams on data capture, LIMS integration, and analytics for traceability and fast turnaround. Manage qualification of reagents, standards, calibrators, and controls; perform bridging and lot comparability studies. Design sample handling workflows addressing matrix selection, stability, freeze–thaw, parallelism, and selectivity for clinical samples. Act as technical SME during client reviews and audits in coordination with QA. Participate in scientific reviews, technical discussions, and operational planning to ensure team alignment. Support assay activities across product lifecycle stages, from early development to clinical submission. Promote a culture of ownership, curiosity, and continuous improvement. Represent assay development in cross-functional teams and strategic projects. Monitor and report site research KPIs and trends internally and externally. Lead risk management and mitigation using data-driven approaches. Drive innovation and digital tool adoption to improve operational efficiency. Required Skills Bachelor’s, Master’s, or PhD in Biochemistry, Molecular Biology, Bioengineering, or a related discipline. At least 5 years’ experience leading bioanalytical assay development and validation with demonstrated project ownership. Proven expertise in implementing and qualifying various ligand-binding assays (e.g., ELISA, MSD), nucleic acid methods (qPCR, ddPCR, NGS), and multiplex platforms (such as NULISA, Olink, Simoa, Luminex). Experience with cell-based immunoassays (neutralizing, metabolic/permeability, flow cytometry) is a plus. Strong collaboration, communication, and decision-making skills within matrixed or cross-functional teams. Excellent written and verbal communication skills, capable of engaging effectively with executive leadership and external stakeholders. Detail-oriented with strong analytical abilities; able to translate technical data into strategic recommendations. Comfortable using modern digital quality management systems and open to leveraging AI-driven tools to enhance compliance and operational efficiency.
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36660 Location:
Boston,MA Job Description A dynamic biotech company is looking for an
Associate or Senior Scientist in Assay Development
to join their on-site team. In this role, you’ll design, optimize, and validate bioanalytical assays that support a cutting-edge, highly automated clinical bioanalysis lab. You will work closely with teams in Automation, Quality, and Software to translate scientific needs into robust, scalable assays that run reliably on a technology-driven platform. This position offers the opportunity to work at the crossroads of biology, automation, and software, contributing directly to innovation in assay development. Responsibilities Develop, optimize, and troubleshoot plate-based immunoassays (e.g., ELISA, MSD/ECL), nucleic acid assays (qPCR, ddPCR), and cell-based/ligand-binding assays for PK, immunogenicity, and biomarker endpoints. Use DOE and statistical analyses to define sensitivity, limits of detection/quantification, precision, accuracy, specificity, linearity, robustness, and stability. Write and execute method development reports, validation plans, and reports compliant with ICH M10 and FDA bioanalytical guidance. Define control strategies, acceptance criteria, and system suitability; implement validated methods under GLP conditions with automation support. Collaborate with automation engineers to deploy assays on liquid handlers and robotic platforms, assisting with scripting, QC, and error handling. Work with software and data teams on data capture, LIMS integration, and analytics for traceability and fast turnaround. Manage qualification of reagents, standards, calibrators, and controls; perform bridging and lot comparability studies. Design sample handling workflows addressing matrix selection, stability, freeze–thaw, parallelism, and selectivity for clinical samples. Act as technical SME during client reviews and audits in coordination with QA. Participate in scientific reviews, technical discussions, and operational planning to ensure team alignment. Support assay activities across product lifecycle stages, from early development to clinical submission. Promote a culture of ownership, curiosity, and continuous improvement. Represent assay development in cross-functional teams and strategic projects. Monitor and report site research KPIs and trends internally and externally. Lead risk management and mitigation using data-driven approaches. Drive innovation and digital tool adoption to improve operational efficiency. Required Skills Bachelor’s, Master’s, or PhD in Biochemistry, Molecular Biology, Bioengineering, or a related discipline. At least 5 years’ experience leading bioanalytical assay development and validation with demonstrated project ownership. Proven expertise in implementing and qualifying various ligand-binding assays (e.g., ELISA, MSD), nucleic acid methods (qPCR, ddPCR, NGS), and multiplex platforms (such as NULISA, Olink, Simoa, Luminex). Experience with cell-based immunoassays (neutralizing, metabolic/permeability, flow cytometry) is a plus. Strong collaboration, communication, and decision-making skills within matrixed or cross-functional teams. Excellent written and verbal communication skills, capable of engaging effectively with executive leadership and external stakeholders. Detail-oriented with strong analytical abilities; able to translate technical data into strategic recommendations. Comfortable using modern digital quality management systems and open to leveraging AI-driven tools to enhance compliance and operational efficiency.
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