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Junior Research Scientist
2 months ago
Position Overview:
The Junior Research Scientist plays a crucial role in supporting CART operations through comprehensive investigation reports. This position involves conducting in-depth root cause analyses, engaging with personnel for interviews, testing hypotheses, and interpreting findings. The incumbent will be responsible for drafting detailed investigation reports, pinpointing corrective and preventive actions (CAPA), and resolving intricate issues. Close collaboration with various functional teams, particularly Quality Assurance, is essential.
Key Responsibilities:
The successful candidate will be expected to:
- Conduct thorough investigations into deviations using root cause analysis methodologies.
- Engage in the CAPA process, ensuring identification and verification of effectiveness.
- Demonstrate strong technical writing abilities and collaborate efficiently within cross-functional teams.
- Understand and apply Global Regulatory and cGMP standards accurately.
- Support inspections from health authorities.
- Utilize data trending and tracking techniques, with proficiency in statistical analysis software being advantageous.
- Exhibit advanced problem-solving skills, technical proficiency, and logical reasoning.
- Prioritize tasks, manage timelines, and adapt to shifting priorities effectively.
- Communicate transparently and effectively with peers and management.
- Utilize electronic Quality systems such as eQRMs or Infinity.
- Possess hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control.
Qualifications:
To be considered for this role, candidates should possess:
- A Bachelor's Degree in a scientific or engineering discipline, preferably in Biochemistry, life sciences, or a related field (an advanced degree is preferred).
- A minimum of one year of relevant experience, ideally in a regulated environment.
- Previous experience in a biopharmaceutical manufacturing setting is advantageous.
- An equivalent combination of education and experience may be acceptable.
Work Environment:
This position entails:
- 80% to 90% of time spent in an office environment.
- 10% to 20% of time in a manufacturing or laboratory setting.
- Occasional travel between sites for training or corporate events.
- Flexibility to work extended hours, weekends, or holidays as necessary to meet project deadlines.
