Chemist II

Piramal Pharma Ltd•Lexington, KY

About The Position

The Chemist II performs complex testing of raw materials, in-process materials, and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards. The position is in the Analytical Quality Control department at Piramal Pharma Solutions in Lexington and reports to the AQC Group Lead. The role involves wet chemistry and instrumental analysis, including HPLC and GC testing, along with laboratory documentation, investigations, instrument troubleshooting, and support and training for entry-level QC personnel.

Requirements

Bachelor of Science degree in Chemistry, Pharmaceutical Science, or another closely related scientific field.
At least 5 years of hands-on quality control laboratory experience.
Proficiency with HPLC and GC analysis.
Ability to function as the team subject matter expert regarding chemist duties and overall testing knowledge, and to support the team as needed.
Previous experience working within cGMP guidelines.
High proficiency operating Microsoft Office applications.
Excellent verbal and written communication skills.
Detail-oriented and organized, with the ability to manage conflicting priorities.
Demonstrated ability to work in a team environment supporting a continuous-operation manufacturing facility.
Excellent problem-solving and interpersonal skills.
Ability to follow written instructions and procedures and explain them to others.

Nice To Haves

Experience working with potent and cytotoxic materials.
Experience working with parenteral drug products.

Responsibilities

Perform routine and non-routine wet chemistry and instrumental testing according to SOPs, testing methods, protocols, and compendia such as USP, EP, and JP, with minimum supervision.
Test raw materials, APIs, finished products, stability samples, and cleaning verification samples.
Perform HPLC and 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, and solutions according to SOPs.
Write SOPs, laboratory protocols and reports, memos, and other interdepartmental correspondence.
Initiate and resolve laboratory investigations.
Train and guide entry-level QC personnel and serve as a subject matter expert in laboratory practices.
Peer-review analytical documentation.
Follow laboratory safety procedures and comply with cGMPs and other regulations.
Maintain an organized and neat laboratory.
Purchase laboratory reagents and consumables.