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Senior Research Scientist
2 months ago
The Senior Research Scientist will serve as the single point of study control and overall planning and conduct of the study in accordance with applicable regulatory guidelines and contemporary scientific practice. Additionally, the Senior Research Scientist will ensure that all Good Laboratory Practices (GLP) are met, and that the outcome of the study is valid and reliable.
**Key Responsibilities**
- Study Planning and Execution
- Develop protocols and ensure that the protocol, and any amendments, are approved and followed.
- Ensure all experimental data, deviations, and unanticipated events are accurately recorded and any corrective actions needed are documented.
- Scientific Leadership
- Establish and maintain relationships with industry and scientific thought leaders through effective communication and scientific expertise.
- Develop company's scientific knowledge and expertise in, gene and cell therapy and/or Protein/Immunogenicity assays.
- Quality Assurance
- Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of the study.
- Team Management
- Mentor and guide junior scientists and technicians.
**Requirements**
- Bachelor's degree or equivalent in a scientific-related discipline required. A Master's degree or Ph.D. is preferred.
- Minimum of 10 years of related GLP experience. A combination of higher education and less industrial experience will be considered.
- Strong background of cell and molecular biology, virology, and biochemistry.
- Experience with a wide variety of biochemistry and molecular biology methods for nucleic acid analysis, amplification, qPCR, RT-qPCR, and molecular cloning.
- Experience with regulated studies along with a solid understanding of study design and protocols.
- Knowledge of GLPs and other regulations.
- Excellent analytical and problem-solving skills.
- Excellent verbal and written communication skills; ability to design, interpret, and present scientific data in a team environment is preferred.