Key Responsibilities:
- Attend cross-functional meetings with project leads to understand timelines necessary for E&L studies.
- Work with Development and Manufacturing to make sure requesting DS and DP samples and control samples from relevant studies.
- Document proposal requests and review quotes for studies with external suppliers.
- Interface with Procurement to request Purchase Orders.
- Review extractables study lab protocols to support the platform.
- Review leachables study lab protocols to support molecule-specific DS and DP.
- Review molecule specific methods developed for the leachables studies for qualification / validation criteria.
- Review the strategy documents for the molecule specific leachables study for the DS and DP Container Closure Systems
- Work with Global Packaging engineers in DDCS to obtain samples and information needed for studies.
- Coordinate shipping of samples to external suppliers for E&L studies.
- Organize and help review extractables and leachables study reports provided by external study suppliers prior to completion and then once approved upload to QDocs.
- Provide data integrity review of extractable and leachables study result summaries / reports to share will toxicologists for assessments.
- Perform data integrity review of the regulatory submission sections relevant to E&L assessments. .
Educational Requirements:
- BS or MS in Analytical Chemistry, Organic Chemistry, or related field.
Experience Requirements:
- Knowledge or hands-on experience in Analytical Chemistry, especially those in sample preparation and analysis of organic compounds and related species using various analytical techniques, e.g. GC-MS, GC-FID, LC-PAD-MS, ICP-MS, HPLC-CAD/ELSD, ion-chromatography, TOC, NMR, etc.
- 7-10 years of relevant experience in Extractable Leachables assessment or other relevant analytical development areas
- Experience in identification of organic compounds and degradants using advance mass spectrometry techniques (e.g., high-resolution tandem mass spectrometry).
- Knowledge of relevant regulatory guidance (e.g., USP, ICH) on analytical methods and extractable and leachable studies.
- Familiarity with Microsoft Office Tools. Skills in Power BI or computer programming languages and database tools is desirable.
- Excellent written and oral communication skills.
- Excellent critical thinking capability and attention to details.
- Highly organized and efficient in executing complex tasks under tight timeline.
- Highly motivated to learn new knowledge and skills.
- Ability to collaborate effectively with others in a fast-paced multifunctional team environment.
Additional Information :
You could connect with me via LinkedIn at https://www.linkedin.com/in/karishma-narang-a45131209/
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