Associate/Senior Scientist—Assay Development

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.