Analytical Scientist I
Summary:
Our client is a leading pharmaceutical manufacturer looking for an Analytical Scientist I to join their team. The successful candidate will be responsible for the development and validation of analytical methods for the testing of drug substances and drug products.
Responsibilities:
- Develop and validate analytical methods for the testing of drug substances and drug products.
- Perform routine analysis of drug substances and drug products.
- Perform method verification for USP methods.
- Write and review standard operating procedures, analytical methods, and validation protocols.
- Participate in analytical method transfer activities.
- Maintain and troubleshoot analytical instrumentation.
- Ensure compliance with all regulatory requirements.
- Communicate analytical results & preparing the relevant documents,-SOP's
Skill Qualifications:
- Analytical method development & validation--wet chemistry techniques
- HPLC, UPLC, GC, UV/VIS, FTIR, LCMS, ICP-Ms, dissolution apparatus, particle size analyze etc
- USP Method Verification.
- Strong communication skills--Written & Verbal
Requirements:
- B.S. with 6 years of Pharma Industry experience in analytical development.
- Familiarity with cGMP/GLP, FDA, ICH and regulatory guidelines
- Work authorization required.
