Chemist II

Piramal Pharma•Lexington, KY

About The Position

The Chemist II works in Analytical Quality Control for Pharma Solutions in Lexington. Reporting to the AQC Group Lead, the role 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 supports a continuous-operation manufacturing facility and requires work with routine and non-routine wet chemistry and instrumental analyses according to SOPs, testing methods, protocols, and compendia.

Requirements

Bachelor of Science in Chemistry, Pharmaceutical Science, or another closely related scientific field.
At least 5 years of hands-on laboratory quality control experience.
Proficiency with HPLC and GC analysis.
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.
Ability to work in a team environment supporting a continuous-operation manufacturing facility.
Excellent problem-solving, communication, and interpersonal skills.
Ability to follow and explain written instructions and procedures.
Ability to function as the team subject matter expert on chemist duties and testing knowledge, and provide team support as needed.

Nice To Haves

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

Responsibilities

Perform routine and non-routine wet chemistry and instrumental testing according to SOPs, testing methods, protocols, and compendia, with minimum supervision.
Test raw materials, APIs, finished products, stability samples, and cleaning verification samples.
Perform HPLC and GC analyses.
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.
Perform peer review of analytical documentation.
Follow laboratory safety procedures and comply with cGMPs and other regulations.
Maintain an organized and neat laboratory.
Purchase laboratory reagents and consumables.