Analytical Scientist

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