Method Development Expert
1 week ago
Key Responsibilities:
- Perform testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
- Record and report results of analyses in accordance with lab procedures, GDP, and ALCOA.
- Create documentation detailing results (e.g. Certificate of Testing, Reports, PowerPoint Slides).
- Review and interpret analytical test results. Make recommendations based on data.
- Conduct method development experiments designed by SMEs.
- Write and execute method validations.
- Recognize and report deviations, validation discrepancies, or unexpected results.
- Maintain a clean and organized laboratory workspace consistent with management expectations.
- Clean and calibrate analytical instrumentation as needed.
- May interact with customers and auditors.
- Collaborate with various functional areas to meet project and team objectives.
- Manage projects at the task level under minimal supervision.
- Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.
- Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.
- At least 1 year of experience working in a regulated laboratory environment. GMP experience preferred.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- 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).
- Good attention to detail and critical and logical thinking skills.
- Ability to read, analyze, and interpret technical procedures and governmental regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Ability to work on multiple projects simultaneously.
- Typically requires standing and walking for a shift.
- Occasionally requires lifting of up to 20 pounds.
- Requires manual dexterity and visual abilities.
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