Sample Operations Specialist
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Sample Operations Specialist - Drug Metabolism, Pharmacokinetics and Bioanalysis
The Drug Metabolism, Pharmacokinetics and Bioanalysis (DMPK-BA) department at AbbVie Biotherapeutics Inc currently in Redwood City, CA transitioning Fall 2021 to South San Francisco is looking for a Project Specialist, Sample Operations. This global department is responsible for ligand binding and FACS-based biomarker analysis from preclinical and clinical studies for oncology, as well as therapeutic areas including Neuroscience, Immunology and Virology.
- 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 regarding sample chain of custody.
- Perform QC reviews of laboratory testing data and laboratory notebooks to ensure compliance with relevant guidelines and SOPs.
- Responsible for contracting labeling, storage, and disposition of critical reagents.
- 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.
**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**
Significant Work Activities
Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
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.