Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica , Venclexta , and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics (ABR), AbbVie's Center of Innovation in Oncology Research and Development, located in Redwood City, CA. ABR R&D efforts focus on two key areas:
Immuno-Oncology (I-O): developing therapeutics that activate the immune system to recognize and eliminate cancer cells
Antibody drug conjugates (ADCs); antibodies conjugated to potent toxins for directed delivery to cancerous cells while sparing healthy tissues.
The Drug Metabolism and Pharmacokinetics Bioanalysis department at AbbVie Biotherapeutics Inc in Redwood City, CA is looking for a Project Specialist, Sample Operations .
Key responsibilities include:
Handles shipment, receipt, storage and transfer of biological samples in support of clinical and preclinical trials. Ensures end-to-end chain of custody documentation.
Responsible for study setup in the bioanalytical research LIMS software based on defined timelines and standards.
Ensures the correct storage and tracking of the biological samples in LIMS.
Maintains knowledge of current regulations related to the sample handling and ensures that reconciliation is achieved to deliver assay-ready samples to testing teams.
Ensure collection, delivery, analysis, and disposition of biological samples under the highest standards of quality, ethics, compliance, and in accordance with informed consent.
Interacts closely with bioanalytical scientists, Laboratory Sample Operations Group, Clinical Sample Operations, and project team leads and/or therapeutic area liaisons with regard to sample chain of custody.
Perform QC reviews of laboratory testing data and laboratory notebooks to ensure compliance with relevant guidelines and SOPs.
B.S. or M.S. and at least 3+ years relevant experience in bioanalytical areas required.
Chemistry, biology and immunology background preferred.
Expertise in LIMS Systems for sample handling and tracking storage preferred.
Experience working under GLP/GCP regulation preferred.
Ability to handle multiple tasks and detail oriented.
Ability to prioritize and adapt to change.
Very good organizational skills.
Excellent interpersonal and communication skills, interfacing with departments and external partners
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Learns fast, grasps the \\\"essence\\\" and can change course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic .
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