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Department Summary
Biospecimens are among Roche’s most valuable physical assets; samples with associated data are critical to all phases of Research and Development (R&D) projects. In this role, you will support Pleasanton’s Biospecimen Acquisition and Management (BAM) subchapter as a Biospecimen Senior Specialist. BAM is strategically positioned within the Development Services and Integration (DSI) chapter of Roche Diagnostics Solutions’ R&D organization. BAM is a global service function supporting the acquisition, characterization, and management of human and non-human biological materials.
Reporting to the BAM Acquisition Team Lead, you will oversee clinical biospecimen and data requests across a diverse project portfolio. You will provide end-to-end management of the acquisition lifecycle, ensuring seamless delivery to key stakeholders. By collaborating with local and global partners, you will align sample requirements with internal processes and industry standards. This role includes managing end-to-end data integrity of the acquired biospecimens—from quality checks and data imports to inventory exports—while upholding the highest standards of data privacy, Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory compliance to safeguard patient trust.
This position is based in Pleasanton, CA, on site (3 days a week on site, approximately).
The Opportunity
End-to-End Workflow Management: Drive the full lifecycle of sample acquisition and data management to ensure customer requests are fulfilled accurately and on time.
GxP Compliance & Data Integrity: Manage information within LIMS frameworks, maintaining rigorous documentation standards and data quality in accordance with validated GxP regulations.
Cross-Functional Leadership: Partner with R&D, Legal, and Logistics teams to align project requirements, manage global stakeholders, and represent the focus area in high-level meetings.
Strategic Problem Solving: Serve as a Subject Matter Expert (SME) to guide decision-making, manage complex requests autonomously, and influence project strategy through scientific expertise.
Risk & Agility Management: Proactively identify and escalate project risks while adapting to shifting priorities to meet strict deadlines and quality standards.
Who You Are (Required)
You have a Bachelor's degree in a scientific discipline.
You have 3 years experience applying broad knowledge in molecular biology or clinical studies along with an understanding of medical device development (especially assays) or experience in the technical and ethical aspects of biospecimen utilization, clinical operations, or sample management.
You are someone who has experience in clinical data management, clinical research, clinical trial operations or biospecimen management.
You have demonstrated success being part of a high-performing team environment, thinking strategically and excelling in cross-functional collaboration.
You are someone who is committed to developing your skills to better yourself and your team.
Preferred Skills, Knowledge and Qualifications
You have an advanced degree in a scientific discipline.
You have prior experience navigating a highly complex, global environment to align cross functional stakeholders.
Experience in SQL, Python and R is preferred.
Your skills will help transform fragmented vendor provided datasets into a standardized data manifest, ensuring that every sample used by Roche is ethically and legally compliant.
Relocation benefits are not available for this position.
The expected salary range for this position is based on the primary location of California 79 500,00 - 147 700,00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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