Implementation Manager

Job Title:Implementation Manager Department:Laboratory Operations / Program Implementation Reports To:Director of Operations Position Summary: The Implementation Manager plays a critical role in coordinating cross-functional initiatives across research, inventory, manufacturing, lab operations, and automation to ensure timely and compliant deployment of new tests, platforms, workflows, and laboratory capabilities. This role bridges scientific, operational, and engineering functions to implement solutions that enhance efficiency, throughput, and quality in a regulated clinical diagnostic environment. Key Responsibilities: • Cross-Departmental Coordination: Serve as the central point of contact for new project rollouts requiring collaboration between R&D, Inventory Management, Manufacturing, Lab Operations, and Automation Engineering teams. • Project Management: Lead end-to-end implementation of laboratory initiatives including new test launches, automation workflows, production scale-ups, and infrastructure changes. Define project scope, timelines, resource allocation, and success metrics. • Workflow Deployment: Translate research concepts or operational needs into practical workflows, ensuring alignment with instrumentation capabilities and automation design. Facilitate dry runs and pilot phases before go-live. • Inventory & Manufacturing Readiness: Coordinate with supply chain and production teams to ensure reagent availability, BOM alignment, kit assembly readiness, and production capacity for launch readiness. • Process Documentation & Compliance: Ensure validation protocols, SOPs, change control forms, and training documents are created and executed in alignment with CAP, CLIA, and NYSDOH guidelines. • Regulatory & Quality Alignment: Interface with QA/RA to ensure implementation activities are audit-ready, documented, and traceable, including proper documentation of assay validations and manufacturing records. • Issue Resolution & Risk Mitigation: Proactively identify risks, dependencies, and operational gaps. Troubleshoot implementation barriers and coordinate corrective actions across departments. • Performance Tracking & Handoff: Monitor project KPIs post-implementation and ensure smooth transition of ownership to operations, production, and support teams. Conduct post-mortem analysis to improve future rollouts. Qualifications: • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or related field. • 3–7 years of experience in a clinical laboratory, diagnostics manufacturing, or research implementation environment. • Strong working knowledge of CAP, CLIA, and NYSDOH regulations. • Experience leading multi-functional projects involving assay development, lab automation, and supply chain readiness. • Familiarity with molecular diagnostics platforms (e.g., qPCR, NGS, ELISA, LC-MS/MS) and LIMS integration. • Excellent communication, documentation, and organizational skills. • PMP, Lean Six Sigma, or equivalent project management certification preferred. Job Type: Full-time Pay: $90,000.00 - $110,000.00 per year Benefits: • 401(k) matching • Dental insurance • Health insurance • Life insurance • Paid time off • Vision insurance Education: • Master's (Required) Experience: • Project management: 3 years (Required) • Jira: 3 years (Required) Ability to Commute: • Santa Clara, CA 95054 (Required) Ability to Relocate: • Santa Clara, CA 95054: Relocate before starting work (Required) Work Location: In person