Scientist II Pharmaceutical Analyst

Cardinal Health•Mansfield, MA

2d•Onsite

About The Position

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. Responsibilities 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. Qualifications 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 <1224>, 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., TrackWise, Veeva or Agile), experience with LIMS (e.g. LabWare) 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. What is expected of you and others at this level 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 LabWare. 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 validation/verification protocols and reports. Possesses working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing is desired. Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.

Requirements

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 <1224>, preferred
Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferred
Knowledge of cGMP regulation/guidance
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
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 validation/verification protocols and reports
Possesses working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing is desired
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures

Nice To Haves

Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferred
Experience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g. LabWare) 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
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 LabWare

Responsibilities

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

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs