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Company | Pfizer |
Address | Los Angeles, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-07-26 |
Posted at | 10 months ago |
Role Responsibilities
- Generate and maintain sterile stocks of molecular buffers and reaction mixes.
- Have familiarity working in regulated environment within a quality system and understand the importance of good documentation practices.
- Handle biospecimens in a molecular diagnostic setting, and familiar with pre-PCR and post-PCR lab procedures..
- Maintain clear and concise documentation of developed processes in a lab notebook
- Hands on experience with molecular lab skills such as PCR setup, DNA/RNA purification and quantification, working in a BSL2 environment under GXP and general safety regulations.
- Experience with nucleic acid analysis techniques such as gel electrophoresis, capillary electrophoresis, sequencing, and understanding of different DNA detection modalities
- Good understanding and compliance with principles of GDP. Maintain clear, concise, and complete development protocols, reports, and lab notebook entries.
- Familiarity with FDA requirements and work experience in regulated and QMS compliant environment.
- Experience in designing and performing molecular assays, such as nucleic acid amplification assays.
- The Scientist will be responsible for assay setups and execution of experiments, experiment design and troubleshooting, occasionally reagent preparation, data analysis and presentation, and diligent documentation of the studies. The Scientist will be independently responsible for a combination of hands-on lab benchwork and office tasks that includes, but not limited to, design and execution of experiments in the lab, troubleshooting and problem solving, authoring test protocols and test reports, data analysis and presentation of results to the scientific team, and mentoring junior members.
- Industry experience in design control life cycle of developing IVD and CE-IVD diagnostic products
- Experience in molecular diagnostics
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