Extractables and Leachables Principal Scientist
Extractables and Leachables Principal Scientist
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
- Performing a large variety of analytical tasks involved in extractables and leachables projects including the development and validation of analytical methods used in the leachable testing of drug products by means of various procedures including HPLC/UV HPLC/MS GC GC/MS and ICPOES
- Reading understanding and interpreting diverse analytical procedures presented in a variety of written styles
- Utilizing technical knowledge in the development of unique analytical methods (including researching projects via literature and internet)
- Performing unknown compound investigations utilizing mass spectrometry working independently and efficiently
- Documenting work clearly and performing tests accurately
- Contacting clients on a routine basis and being responsible for some projects
Qualifications :
Minimum Qualification:
- Bachelors in Chemistry or related science with minimum of 5 years of E/L experience.
- Understanding of regulatory expectations for E/L studies on medical devices and experience designing scientifically sound E&L studies.
Additional Preferences:
- Experience with ISO 10993 and/or ISO 18562 testing
- Participation in industry working groups (e.g. AAMI USP ISO etc.)
- Experience with PFAS testing MS or PhD in chemistry or related science
- Experience in a cGMP GLP and/or ISO 17025 compliant/accredited lab.
- Experience operating LC/MS GC/MS and/or ICP systems.
- Experience with method development and validation.
- Authorization to work in the US without sponsorship.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Key Skills
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