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Junior Research Scientist
2 months ago
Position Overview:
The Associate Scientist/Engineer plays a crucial role in supporting S12 CART operations through comprehensive investigation reports. This position involves conducting detailed root cause analyses, engaging with personnel, testing hypotheses, interpreting findings, and drafting investigation documentation. Additionally, the incumbent will identify corrective and preventive actions (CAPA) and troubleshoot intricate issues, necessitating close collaboration with various functional teams, particularly Quality Assurance.
Key Responsibilities:
- Execute thorough investigations into deviations using root cause analysis methodologies.
- Navigate the CAPA process, ensuring identification and verification of effectiveness.
- Demonstrate strong technical writing capabilities and foster collaboration within cross-functional teams.
- Comprehend and apply Global Regulatory and cGMP standards accurately.
- Support health authority inspections as required.
- Utilize data trending and statistical analysis tools effectively.
- Exhibit advanced problem-solving skills and logical reasoning.
- Prioritize tasks, manage timelines, and adapt to shifting priorities efficiently.
- Communicate transparently and effectively with peers and management across departments.
- Utilize electronic Quality systems such as eQRMs or Infinity.
- Preferably possess hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control.
Qualifications:
- A Bachelor's Degree in a scientific or engineering discipline, ideally in Biochemistry, life sciences, or a related field (advanced degree preferred).
- At least 1 year of relevant experience in a regulated environment.
- Experience in a biopharmaceutical manufacturing setting is advantageous, particularly in CAR T.
- An equivalent combination of education and experience may be considered.
Work Environment:
- The role involves working predominantly in an office setting (80% to 90% of the time).
- The incumbent will also spend time in manufacturing and/or laboratory environments (10% to 20%).
- Occasional travel between sites for training or corporate events may be necessary.
- Flexibility to work extended hours, weekends, or holidays may be required to meet project deadlines.
