Technical Transfer and Assay Development Scientist

Job description

Technical Transfer and Assay Implementation Scientist Summary: As a Tech Transfer/ Assay Implementation Scientist reporting to the Operations Support lead, you will be responsible for the onsite validation, implementation, and operationalization of molecular and immunoassay-based assays (qPCR, dPCR, NGS, and ELISA) to support diagnostic testing at the reference laboratories. The R&D and Medical team sets and approves all medical quality expectations, clinical performance thresholds, and assay acceptance criteria; this role executes against those standards and serves as the operational bridge between assay development and routine scalable clinical testing. Protocol development is a shared activity: Medical leads with input and review from this role. Probe, reagent, and equipment decisions with clinical quality implications are made jointly with medical expertise. ZRL operates a cross-functional model in which the Medical team owns assay design, acceptance criteria, clinical performance standards, and medical quality oversight, while the Operations Support team owns execution, technology transfer, scalability, and day-to-day operationalization. This role serves as the primary operational interface with the Medical team — receiving approved protocols and standards, providing execution feedback and performance data, and collaborating on shared activities such as protocol refinement, SOP development, and training. Decisions with clinical quality implications are made jointly with Medical. Duties: Technology Transfer & Implementation · Lead budgeting for assay design experiments, COGs/ROI evaluation during preliminary assay design, and COGs/ROI verification post-implementation to ensure operational cost-effectiveness. · Lead analytical equipment selection to support assay implementation and operational scalability · Provide input on material transfer agreements as needed. · Own onsite technology transfer and assay implementation into routine diagnostic workflows, serving as the primary operational point of contact for go-live and scale-up activities. This includes transfer of analytical methods from R&D or Medical into routine testing operations, in coordination with the Medical team for clinical validation parameters · Lead reagent operationalization and inventory planning during assay transfer to Operations; coordinate handoff to Operations for day-to-day inventory management. · Implement and operationalize molecular and immunoassay-based assays across multiple platforms (qPCR, dPCR, NGS, ELISA) following approved protocols; provide operational input during protocol development; support joint decision-making with Medical and R&D on probes, reagents, and equipment where clinical quality is implicated · Perform hands-on laboratory work including nucleic acid extraction, ELISA plate preparation, assay setup, and workflow optimization · Troubleshoot assay performance issues and interpret complex datasets to ensure high-quality results · Own equipment qualification and operational readiness (IQ/OQ) and execute performance qualification (PQ) for operations equipment; coordinate with Medical for clinical validation parameters. Validation & Data Review · Execute and document onsite validation studies per approved protocols; author validation reports, SOPs, and technical documentation in accordance with quality systems; escalate protocol gaps or performance deviations to relevant teams- Operations and Medical for review and approval · Perform first-line review and interpretation of assay data and study results; escalate complex or discrepant findings to the Medical team for clinical disposition. · Provide operational performance data and bench-level observations to support annual primer/probe target reviews led by the Medical team. · Partner closely with the Medical and R&D team as the scientific collaborator on assay quality, protocol review/approval, and clinical performance expectations; coordinate with quality and bioinformatics to ensure successful and compliant project delivery · Analyze, document, and present experimental data in technical reports and presentations Quality & Compliance · Develop new assay QC programs under Medical-approved criteria; execute periodic QC review and monitoring, escalating trends or deviations to Medical and Operations leadership. · Develop proficiency testing programs for new assays under Medical-approved criteria; provide technical consultation during proficiency testing execution to ensure ongoing quality. · Provide technical consultation during nonconformance investigations, root cause analyses, and CAPA activities led by the Operations team; contribute subject matter expertise on assay performance and workflow factors as needed. · Maintain compliance with applicable regulatory, quality, and biosafety standards (including BSL-2 practices) in all assay implementation activities. · Author and maintain SOPs and technical documentation in accordance with the ZRL Quality Management System; coordinate with Medical on content related to assay performance criteria, result interpretation, and clinical reporting. · Execute reagent and controls assessments for operational performance; provide data and recommendations to Medical for approval. Training and Leadership · Develop training content for new assay execution in coordination with Operations; submit to Medical for approval of clinical and quality components. · Deliver hands-on training for new assay execution, instrument operation, and workflow procedures in coordination with Operations leadership. · Provide scientific leadership as a subject matter expert for molecular and immunoassay operations. · Prepare for and lead internal and external meetings, including project updates and scientific discussions as needed · Serve as a technical resource and subject matter expert for 2–4 molecular lab technicians within Operations Education/Experience: · Master’s or PhD in Life Sciences (e.g., Molecular Biology, Genetics, Genomics, Biomedical Sciences, Biochemistry, or related field) required. · Certification by American Society for Clinical Pathology (ASCP), including MLS(ASCP), MB(ASCP), and DLM(ASCP), is preferred. · Minimum of 5+ years in a veterinary diagnostic environment or closely related diagnostic/IVD environment. · Familiarity with infectious disease testing, or serological/ELISA-based diagnostics is a plus · Strong foundation in molecular biology, genetics, and genomics technologies · Hands-on experience in assay development using qPCR, dPCR, NGS, and/or ELISA platforms · Demonstrated experience troubleshooting NGS workflows and assay performance issues preferred · Experience working under quality systems (e.g., ISO 13485, CLIA, ISO 17025, AAVLD or similar) preferred Technical Skills Required: · Proficiency with data analysis tools and Microsoft Office Suite (Excel, PowerPoint, Word) · Strong analytical thinking and problem-solving skills · Excellent organizational skills with the ability to manage multiple priorities and projects · Effective communication and collaboration skills across multidisciplinary teams · Self-motivated, detail-oriented, and adaptable in a fast-paced environment · Eagerness to learn and apply new technologies and scientific concepts · Experience with proficiency testing programs preferred. · Familiarity with laboratory information systems (LIS) and result-reporting workflows preferred. Physical Position Requirements: · Full-time, onsite position (Monday–Friday) · Laboratory-based role requiring routine bench work · Ability to lift 30lbs. · Travel 10-15% Full time Regula