Role Summary
The Research Scientist (RS) will be engaged in serving 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 RS will ensure that all Good Laboratory Practices (GLP) are met, and that the outcome of the study is valid and reliable.
Relocation is available for qualified candidates. Candidate must be authorized to work in the US without company sponsorship now or in the future.
Role Responsibilities
- Serve as the Principal Investigator/Study Director/Bioanalytical Monitor for internal and external studies.
- 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.
- Establish and maintain relationships with industry and scientific thought leaders through effective communication and scientific expertise.
- Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of the study
- Develop company's scientific knowledge and expertise in, gene and cell therapy and/or Protein/Immunogenicity assays.
- Drive efficiencies through automation/new technologies in sample preparation, analysis, and reporting.
- Write and review reports and SOPs.
- Communicate with management and Sponsors regarding project issues, changes, and requirements.
- Mentor and guide junior scientists and technicians.
Role 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.
