Scientific Researcher
1 week ago
Indotronix Avani Group is seeking a highly skilled Scientist I to join our team in Bend, OR. As a key member of our analytical development team, you will be responsible for performing method development, method validation, and analytical testing activities for clinical development materials.
Key Responsibilities- Method Development and Validation
- Develop, validate, and execute analytical methods for clinical development materials.
- Collaborate with cross-functional teams to ensure method development and validation meet regulatory requirements.
- Analytical Testing
- Perform analytical testing using various techniques, including HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
- Record and report results of analyses in accordance with lab procedures, GDP, and ALCOA.
- Documentation and Reporting
- Create documentation detailing results, including Certificate of Testing, Reports, and PowerPoint Slides.
- Write and execute method validations.
- Regulatory Compliance
- Ensure all analytical activities are performed in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
- Recognize and report deviations, validation discrepancies, or unexpected results.
- Education
- Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.
- Experience
- At least 1 year of experience working in a regulated laboratory environment. GMP experience preferred.
- Competencies
- Hands-on experience with various analytical techniques, including: HPLC, GC, Dissolution.
- Ability to work independently and in a team setting.
- Strong knowledge of Good Manufacturing Practices and data integrity (ALCOA).
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