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Research Scientist
2 months ago
Position Overview:
The Research Scientist is tasked with conducting thorough investigations to support CART operations. This role involves executing detailed root cause analyses, engaging with personnel, testing hypotheses, and interpreting findings. The successful candidate will be responsible for drafting comprehensive investigation reports, identifying corrective and preventive actions (CAPA), and addressing complex challenges.
Key Responsibilities:
- Lead detailed investigations and analysis to determine root causes.
- Collaborate with various functional teams, including Quality Assurance.
- Author and maintain investigation documentation.
- Identify and implement corrective and preventive actions (CAPA).
- Troubleshoot and resolve complex operational issues.
Essential Qualifications:
- Bachelor’s degree in a scientific or engineering discipline, preferably in Biochemistry or Life Sciences (advanced degree is a plus).
- Minimum of one year of relevant experience in a regulated environment.
- Experience in biopharmaceutical manufacturing is preferred.
Required Skills:
- Proficient in deviation investigations and root cause analysis methodologies.
- Strong technical writing and cross-functional collaboration skills.
- Ability to interpret and apply Global Regulatory and cGMP standards.
- Experience with data analysis and statistical software is advantageous.
- Excellent problem-solving skills and logical reasoning.
Work Environment:
- Primarily office-based with occasional laboratory exposure.
- Flexibility to work extended hours, weekends, or holidays as needed.
