Standards and Stability Analytical Chemist

Overview

Standards and Stability Analytical Chemist. This is the intermediate level technical professional within the Quality Team. Performs analytical tasks accurately and efficiently without supervision to qualify standards and ensure reference materials are available for cGMP analytical testing that support Research and Development, Quality Control, Manufacturing, and external Clients. Supports the Stability Program. Coordinates study initiation, pull schedule, packaging, labeling, analytical testing. Supports laboratory investigations and compilation of stability data and results. Accountable for confirming that stability samples are properly packaged, exposed to the appropriate conditions, tested, and reported as dictated by cGMP.

Responsibilities

• This position supports 24 / 7 stability monitoring / testing. The incumbent must be willing to work weekends and / or nights
• Run routine and non-routine tests on a variety of samples. Test regular and / or special stability study and standard characterization / qualification testing
• Perform equipment calibration, titrant standardization, and Stability chamber Monitoring and Preventative Maintenance
• Identify and perform basic troubleshooting with instruments in the QC Lab. Identify and communicate problems and solutions related to process, procedure, and materials to the group. Basic investigation and take corrective action on anomalous test results
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies including cGMPs
• Perform daily record keeping on SAP and LIMS, enter status changes for materials, initiate incident reports
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
• Attend and participate in Quality and Cross Functional Team meetings which include team huddle. Develop team skills
• Understand the cGMP practices to perform stability testing and standards characterization / qualification testing
• Package stability samples and standard material with the appropriate verified materials
• Authors technical documents for the Standards and Stability Programs such as protocols and reports
• Responsible for critical and time sensitive testing, including high potent material and / or other difficult methods
• Capable of performing basic troubleshooting analytical techniques such as uPLC / HPLC, GC, FTIR, UV / Vis, KF titrations, and other wet chemistry techniques
• Ability to support laboratory investigations and assist investigators to determine root cause
• Provide thorough data review for good documentation practices
• Able to work independently without frequent supervisory oversight

Leadership, Safety & Quality

Qualifications

SALARY Actual pay will be based on your skills and experience.

Benefits

EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire on November 7, 2025

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