You will design, implement, and oversee operational workflows that support the compliant storage and retention of samples in collaboration with the Translational Sciences, Chemistry Manufacturing and Control (CMC) and Research teams. This role will coordinate with the team members that execute daily tasks related to sample management (shipping, storage, processing). Additionally, you will implement a software-based and physical system for receipt, organization, and maintenance of existing and future biospecimens for research and development. This role is responsible for ensuring consistent oversight and execution of sample management, storage, and research processing in support of company priorities and objectives, and will ensure compliance with regulatory, state, and local standards. This role can sit in either our Seattle or South San Francisco office.
KEY ROLE AND RESPONSIBILITIES:
- Lead all sample operations including, shipment, receipt, verification, labeling, inventory, storage, retrieval, and distribution of human biological specimens
- Develop and maintain SOPs and Plans pertaining to biological sample storage
- Manage stakeholder requests and transfer of specified samples from freezer inventory in accordance with applicable regulations. Ensure sample requests from collaborators and partners are fulfilled in a timely manner
- Maintain organization of controlled temperature units in the biorepositories (i.e., freezer, refrigerator, etc.)
- Monitor capacity of storage facilities to ensure sufficient space is available for current and future projects
- Anticipate, plan and work collaboratively with Translational Sciences, Chemistry Manufacturing and Control (CMC) and Research leads in maintaining biorepository capacity
- Ensure alignment between physical and electronic inventory of clinical specimens
- Accountable for electronic records management and tracking relevant biospecimen information (e.g., volume, freeze-thaws cycles, media, etc.), ensuring information is maintained with accuracy
- Partner with Translational Sciences team to select, implement and enforce the use of an electronic sample management system, and associated processes
- Manage sample and data input and tracking in the sample management system.
- Collaborate with Translational Sciences to qualify, review, and manage biological material service providers
- Propose, implement, and improve sample management processes with best practices. biosafety, and productivity in min
- Maintain and monitor inventory of laboratory supplies
- Coordinate compliant shipments of sample materials and applicable supplies with Translational Sciences, Chemistry Manufacturing and Control (CMC) and Research leads
- Adhere to, and train staff to appropriate biosafety regulations, relevant department SOP’s and internal tracking processes and systems
- Effectively communicate all sample management affairs as needed and provide data, reports, and documentation as requested
- Report sample repository activities and specimen status to leadership as needed
- Other duties as assigned
- Bachelor’s Degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field with a minimum of 12 years clinical sample management and/or repository experience
- Demonstrates experience working with cross-functional teams
- A minimum of 5 years’ experience in a people management role
- Proven experience as a strong collaborator, effective at influencing internally and externally, and proactive in a fast-paced environment
- Demonstrated work experience in a highly regulated environment (GMP or GLP)
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent verbal and written communication skills required.
- Excellent organizational, multi-tasking and time management skills required.
- Demonstrated leadership ability, critical thinking ability, problem-solving skills and ability to make independent decisions
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.