Job Details
Overview:
This CDMO in East Windsor is looking for an Analytical Scientist to come and join their team working in a fast paced environment. This individual will be responsible for handling method development and validation for small molecule projects, utilizing HPLC, GC and other analytical lab instruments.
Responsibilities:
- Support Analytical Laboratory Services in enhancing and maintaining laboratory operations and protocols.
- Conduct various scientific analyses to assess the quality of raw materials, in-process materials, and finished products.
- Draft detailed analytical development and validation protocols.
- Design, execute, and validate chemical assays and analytical methods, including HPLC for cleaning verification.
- Collect and analyze samples for routine equipment cleaning validation.
- Interpret and document analytical test data accurately.
- Troubleshoot analytical methods and equipment issues as they arise.
- Generate Certificates of Analysis and prepare comprehensive analytical reports.
- Maintain organized raw data records for review purposes.
- Document analyses in laboratory notebooks, worksheets, or batch records.
- Conduct peer reviews of laboratory records for accuracy and completeness.
- Promptly escalate quality or compliance concerns to Line Manager and Senior Management.
- OOS and OOT
- results and communicate findings to relevant departments.
- Provide support for environmental monitoring activities as needed.
- Adhere to SOP's, cGMPs, and other regulatory standards.
- Lead a team of analytical scientists and technicians