Biorepository Manager, Contractor
151 Oyster Point Blvd, South San Francisco, CA 94080
Summary / Overall Purpose
Represents Preclinical Translational Biology (PTB) for all activities regarding biologic sample management. Responsible for managing the on-site biorepository for preclinical and clinical biological samples and provide visibility and control of samples globally. Tasks include sample tracking, storage, retrieval and reconciliation of biological samples. Additional tasks include ensuring sample integrity and maintaining GCP compliance for biologic study samples.
Essential/Primary Duties, Functions and Responsibilities
- Manage specimen sample tracking, receiving, and storage processes for internal biorespository.
- Ensure sample integrity and maintain GCP compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions.
- Assist in the development and maintenance of a biorepository database (e.g. Laboratory Information Management System).
- Interface with laboratory personnel, specimen processing vendors, and other vendors as needed to ensure proper shipment of specimens, respond to issues as needed, and to ensure study objectives are met.
- Coordinate incoming and outgoing study supply shipments as needed.
- Partner with the Biomarker Manager to assist the Clinical Study teams and PTB to execute sample specimen collection strategy including but not limited to storage and management of biologic specimens (e.g., PK, PD, Genomics, Biomarkers, etc.) in concurrence with sites and Central Laboratories as appropriate.
- Identify and escalate issues appropriately.
- Reviews status of samples received and completeness of data and create reports for study teams when requested.
- Participates in process improvement projects under the direction of manager.
- Supports manager in providing projections for annual and long term planning.
- Minimum of 2-3 years Sample Management experience, including 2-3 years’ work experience in related laboratory experience, or scientific related field and/or training; or equivalent combination of education and experience.
Management of Staff:
Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
- Knowledge of clinical laboratory specimen handling.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Excellent analytical and assessment skills.
- Excellent judgment and problem solving skills.
- Demonstrated project and operational management experience (e.g. effectively managing relationships with key internal stakeholders as well as external collaborators).
Customer & Industry Knowledge:
- Prior handling and knowledge of databases and inventory software such as LIMS.
- Technical knowledge to maintain electronic files.
- OSHA Training/Biological Specimen handling.
- Bachelor’ s Degree in Sciences recommended, but not required
Other Requirements (list any other requirements not identified above, for example, ability to prioritize multiple tasks, ability to work under pressure, ability to work with others, oral or written communication skills, travel requirements, and the like):
- Ability to juggle multiple tasks and competing priorities.
- Excellent planning and coordination skills.
- Considerable flexibility.
- Keen sense of quality and execution.
- Entrepreneurial spirit with “ can do” attitude, commitment to teamwork, and initiative
- Track record of being a valued team player: organized, trustworthy, collaborative, committed to achieving difficult goals.
- Seeks change & values innovation.
- Attention to detail.
- Advanced planning and organization skills.
- Effective oral and written communication skills.
- Ability to work effectively in a cross-functional team matrix environment.
- Advanced critical thinking skills.
- Intermediate project management, time management and problem solving.
- Advanced computer operations skills.
- Experience representing company to outside vendors.