Senior Business Process Specialist – Biospecimen

Role: Senior Business Process Specialist – Biospecimen

Location: Pleasanton, CA (On-site).

Duration: 12+ months

About the Role

We are seeking an experienced Business Analyst / Consultant to support digital transformation initiatives within Research & Development (R&D), with a strong focus on laboratory systems and process optimization. This role will support the implementation of a new Laboratory Information Management System (LIMS) and play a key role in driving operational excellence, data governance, and regulatory compliance across global R&D operations.

In this role, you will act as a key consultant, partnering closely with scientific, technical, and business stakeholders to assess current-state processes, identify gaps, and define clear functional and technical requirements to enable successful system implementation and adoption.

This role supports a strategic digital transformation program aimed at retiring legacy laboratory tools and implementing a modern, scalable LIMS for biospecimen and laboratory data management. The program focuses on improving process efficiency, data integrity, compliance, and integration across digital lab technologies.

Key Responsibilities

Digital Tool Consulting & Integration

• Support the migration from legacy laboratory systems to a unified LIMS platform, ensuring a smooth transition and full divestment of legacy tools by target timelines.
• Partner with cross-functional teams to ensure seamless integration with existing digital lab technologies and enterprise systems.
• Advise on best practices for system configuration, data migration, archival, training, and validation.

Process Improvement & Operational Excellence

• Lead process improvement initiatives using Lean / Lean Six Sigma methodologies to reduce inefficiencies and improve laboratory operations.
• Facilitate operational excellence and process-mapping workshops across multiple functions.
• Conduct current-state and future-state assessments to identify functionality gaps and scalable solutions aligned with R&D objectives.

Business Analysis & Stakeholder Engagement

• Engage with R&D scientists, engineers, and technical teams to gather, document, and validate business and system requirements.
• Translate scientific and operational needs into clear, unambiguous functional and technical requirements for vendor implementation.
• Evaluate implemented solutions to measure value realization and recommend continuous improvements.

Data Governance, Quality & Compliance

• Advise on adherence to FAIR data principles, GDPR, and global data privacy and regulatory requirements.
• Ensure systems support audit-ready documentation, traceability, and secure management of biospecimens and experimental data.
• Collaborate with IT and digital teams to enable a strong data backbone supporting automation, connectivity, and emerging technologies (e.g., sensors, IoT).

Qualifications

• 5+ years of experience in business analysis, consulting, or process improvement roles in the biopharmaceutical and diagnostics industry.
• Proven experience applying Lean, Lean Six Sigma, or similar methodologies in complex environments. Related certification is a must.
• Hands-on experience implementing or supporting modern LIMS and biorepository platforms; familiarity with system integrations and complex digital ecosystems.
• Strong understanding of biospecimen lifecycles, laboratory workflows, ethics, and data privacy considerations. A scientific background is a big plus.
• Ability to leverage connected data to generate insights and support data-driven decision-making.
• Demonstrated experience in change management and driving the adoption of new digital tools and enabling cultural shifts toward standardized, data-driven processes.
• Strong communication skills with the ability to engage effectively with both technical and non-technical stakeholders, including senior leadership.
• Self-motivated individual who can maintain the quality, accuracy, and timeliness of deliverables.
• Strong interpersonal skills and the ability to build effective working relationships inside and outside their functional area.
• Ability to work in a fast-paced, dynamic environment with efficiency, and capable of handling multiple projects.