Chemist II

Chemist II

Business: Pharma Solutions Department: Analytical Quality Control Location: Lexington

Job Overview

Reporting to the AQC (Analytical Quality Control) Group Lead, 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.

Shift: Days

Reporting Structure: This position reports to the AQC Group Lead.

Key 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.

Qualifications:

• Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field

• Minimum 5+ year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis

• Function as the team SME with regard to chemist duties and overall testing knowledge; provide team support as needed.

• Previous experience working within cGMP guidelines

• Experience working with potent, cytotoxic materials and parenteral drug products preferred

• High level of proficiency operating all Microsoft Office applications

• Excellent communication skills, both verbally and in writing

• Detail oriented and organized; able to manage conflicting priorities

• Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility

• Excellent problem solving, communication, and interpersonal skills

• Ability to follow and can also explain to others written instructions and procedures.