- Provide operational support for acquisition and management of human biological samples collected for biomarker and other research purposes to help achieve the goals of the Biomarker Sciences Group.
- Plan, schedule and perform on-site receiving, accessioning, and distribution of samples from commercial vendors and academic collaborators as well as Gilead clinical studies and Investigator Sponsored Trials (ISTs) to fulfill approved sample requests
- Monitor sample delivery, sample quality, and performance of vendor according to contract
- Maintain information on sample vendors regarding inventory, sample costs, sample collection services and performance
- Perform biomarker sample aliquoting to conserve samples on request and barcode and accession child samples into inventory.
- Maintain sample accessioning laboratory equipment and processes for receipt, accessioning, aliquoting, storage and distribution and associated controlled documents to ensure regulatory compliance.
- Collect, organize and curate information on samples collected from commercial vendors and academic collaborators as well as Gilead clinical studies, Investigator Sponsored Trials (ISTs) for loading into biomarker research database.
- Maintain records of sample inventory and acquisition information and document curation activities according to business needs and in compliance with regulatory standards.
- Develop and follow biomarker sample management business processes and standard operating procedures (SOPs).
- Use biomarker research database and other reporting tools according to SOPs.
- Maintain accessioning laboratory processes and equipment in compliance with biosafety and quality standards and interact with infrastructure support groups.
- Work effectively with colleagues in Biomarker Sciences and Research Biology Groups to fulfill sample needs, and obtain input on scientific /technical issues.
- Work effectively with colleagues in Biomarker Sciences Group and other departments to align activities while performing responsibilities.
- Identify potential ways to streamline lab processes and/or management of sample information and work in team setting to implement.
Knowledge, Experience and Skills:
- MS in life science or clinical discipline with 4 or more years of relevant industry experience or BS in life science with 5 or more years of relevant industry experience.
- Laboratory experience in biological sample management
- Experience in biological sample data curation
- Experience in facilitating and managing quotes and contracts from external service vendors
- Experience using Excel and/or scientific/clinical databases; database validation experience a plus.
- Familiarity with drug development process and compliance requirements.
- Attention to detail and ability to track and help resolve open issues.
- Excellent teamwork, communication, decision-making and organizational skills required.
- Must be able to prioritize multiple tasks using planning, organizational and time management skills.