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Department Summary
As a Biospecimen Senior Specialist within the Biospecimen Acquisition and Management (BAM) subchapter, you will play a pivotal role in fueling Roche’s Research and Development (R&D) innovation by managing the end-to-end lifecycle of critical biological assets. You will lead the design, planning, and execution of sample acquisition, ensuring that materials are procured and characterized in strict alignment with global regulatory standards, including Good Clinical Practice (GCP), Good Clinical Practice (GLP), and ethical guidelines. By collaborating with a diverse network of internal and external stakeholders, you ensure that the biological needs of R&D teams are met efficiently while upholding Roche’s core quality principles.
In addition to acquisition, you will serve as a Laboratory Information Management System (LIMS) Power User responsible for the integrity and security of biospecimen data. This involves overseeing data entry, performing complex imports and quality checks, and ensuring all information adheres to Findability, Accessibility, Interoperability, and Reuse (FAIR) data principles and privacy regulations such as General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA). You will be expected to operate with high autonomy—proactively managing risks, resolving data discrepancies, and aligning with global teams to ensure that biospecimen data remains a high-quality, reusable asset that supports the development of future diagnostic solutions.
This position is based in Pleasanton, CA, on site.
The Opportunity
End-to-End Workflow Management: Orchestrate sample acquisition and biological material fulfillment, ensuring customer requirements are met through cross-functional partnership with R&D, Legal, and Logistics.
Data Integrity and Good Practice (GxP) Compliance: Manage complex information within LIMS and other databases, adhering to strict validated standards and GxP regulatory requirements.
Advanced Tool Development: Design and implement new applications and guidelines to streamline data collection, manipulation, and analysis of complex datasets.
Quality Assurance and Reconciliation: Oversee rigorous data review and collaborate with external providers to resolve ambiguities and reconcile inconsistent data into high-quality structures.
Strategic Project Leadership: Act as a subject matter expert in global stakeholder meetings, proactively managing risks and delivering project outcomes with minimal oversight.
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.
RMSCC, microbiology, bacteria, or cell knowledge background is highly preferred.
You have prior experience navigating a highly complex, global matrix environment to align cross functional stakeholders.
Experience in SQL, Python and R.
Data wrangling and data processing in R/Python to support the summarization and interpretation of clinical trial data.
Experience wrangling data from disparate sources, data cleaning, and harmonizing datasets for analysis.
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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