Chemist II

Piramal Enterprises - Lexington, KY

Full-time - Mid Level

Lexington, KY

Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

The primary purpose of the role is to perform complex testing of raw materials, in-process and finished products, maintain and calibrate analytical instruments in compliance with cGMP standards.

Responsibilities

• Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc. with minimum supervision.
• Testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
• Proficient at HPLC/GC analysis
• Document laboratory work according to GDP, cGMPs, and SOPs
• Troubleshoot, calibrate and maintain instruments as required.
• Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
• Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
• Initiate and resolve laboratory investigations.
• Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.
• Perform peer review of analytical documentation.
• Follow safety procedures when working in laboratory.
• Understand and comply with cGMPs and other regulations.
• Maintain the laboratory in an organized and neat manner.
• Purchasing of laboratory reagents and consumables.

Requirements

• Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
• Minimum 3+ year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis
• Previous experience working within cGMP guidelines
• Experience working with potent, cytotoxic materials and parenteral drug products preferred