Sr Manager, Software Development
CurrentResponsibilities:• Managed, led and rebuilt Software teams for Noninvasive Prenatal Testing (NIPT), TruSight Oncology (TSO), and Whole Genome Sequencing (WGS) for Illumina Lab Services (ILS) projects• Led design and implemented:o NIPT projects: Accelerate Analysis pipeline, Copy number variation (CNV), and Early Pregnancy Loss o COVID projects: Clinical Affairs Saliva Study, Employee COVID Testing, and CDC Sequencing-Based COVID-19 Surveillanceo TruSight Oncology, Pharma and WGS projects: Accessioning system for Laboratory Developed Tests (LDTs) and Pharma Research Use Only (RUOs)• Integrated systems and devised strategic plans, resulting in a significant cost reduction of over 1 million• Developed roadmaps for engineering teams, gathered requirements, and prioritized projects• Proficient in Project Management, overseeing Agile-Scrum Sprints, Epics, Stories, refinements, backlogs, releases, and rollout plans• Planned, designed, and implemented comprehensive laboratory software systems, including LIMS, automation, and critical solutions for a high-throughput genomics laboratory• Developed and grew leadership talent through effective mentoring, succession planning, and retention strategies in a fast-paced environment• Ensured compliance with Regulatory Standards: HIPAA, EU GDPR, CLIA, IEC 62304, ISO 14971, ISO 13485, ISO 20387, GCP, and FDA 21 CFR Part 11• Support and participate in Audits for CLIA, CAP Audits, Internal annual Audits, and annual HIPAA Privacy and Security assessments• Ran Information Security program for ILS and Subject matter expert on cyber security and data privacy• Developed Patient, Provider, Physician, and Billing portals complying with HIPAA and GDPR regulations• Developed Laboratory workflow LIMS system, integrating with Public Health systems via EDI HL7• Participated in hands-on coding within a continuous deployment environment• Provided technical guidance to internal/external customers for EDI integration