Scientist II Pharmaceutical Analyst

What Chemistry Services Center contributes to Cardinal Health

Chemistry Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality, Regulatory & Medical Affairs (QRMA) Scientific Services. Under the umbrella of QRMA, Chemistry Services Center will use specialized instruments to perform Assay and impurity/degradant tests for stability program for solid dose pharmaceuticals.

This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.

• As an experienced analytical chemist in Pharmaceutical Analysis Department, produces high quality data for pharmaceutical stability analyses.
• Perform data compilation, review, evaluation and trend analysis on data as applicable.
• Perform analytical testing on stability samples using various techniques like HPLC, GC, UV-Vis, Karl Fisher and dissolution testing to assess drug product stability.
• Ensure accuracy and precision of analytical methods by adhering to established quality control procedures.
• Ensure all stability testing is conducted according to cGMP principles.
• Perform analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
• Perform investigations of Out of Specification (OOS) test results as needed follow FDA guidelines.
• Maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to stability studies and data documentation.
• Communicate stability data findings to stakeholders through reports.

• Bachelor’s degree in chemistry or a related scientific field, preferred or equivalent work experience.
• 2-4 years of analytical laboratory experience performing analyses using HPLC, GC, UV-Vis, Karl Fisher and dissolution testing to support pharmaceutical stability testing, preferred
• Experience with commercial stability programs following ICH guidelines, preferred
• Experience with analytical method verification and validation following regulatory guidelines, preferred
• Experience with analytical method transfer following regulatory requirements such as USP , preferred
• Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferred
• Knowledge of cGMP regulation/guidance.
• Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferred
• Experience with quality management systems (e.g., Track Wise, Veeva or Agile), experience with LIMS (e.g., Lab Ware) is a plus.
• Proficient in the use of instrumental data systems, including data acquisition, analysis and processing (e.g., Waters’ Empower software and Mettler Toledo’s Labx) , preferred
• Must be able to convey recommendations, data, observations, results, and problems accurately and effectively to co-workers, customers and management.
• Ability to handle multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Good communication and interpersonal skills. Can operate independently with minimal guidance and supervision and a team player.

• Produces high quality data and provides are able to provide interpretations of pharmaceutical stability analyses.
• Experience with data chromatography acquisition software such as Waters Empower desired.
• Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as Lab Ware.
• Reports test data in a form and format that facilitates the use of the data by team members.
• Work with lab manager and senior staff members of pharmaceutical analysis department, develops instrument testing protocol and methods, standard operating procedures (SOPs), work instructions and other instrument documentation.
• Ensures that the necessary testing is performed according to the test specification, test method and to ensure testing is completed in a timely and efficient manner.
• Work with senior chemists, participate in preparations of analytical method transfer and…