Scientist III, 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 testing for solid dose pharmaceuticals. This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.

Responsibilities:

• As a subject matter expert (SME) 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 studies are conducted according to cGMP principles.
• Develop and execute analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
• Analyze stability data and identify trends.
• 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.
• Collaborate with cross-functional teams including Quality Assurance, and Regulatory Affairs and other stakeholders to discuss stability concerns and address issues.
• Communicate stability data findings to stakeholders through reports.

Qualifications:

• Bachelor's degree in chemistry or a related scientific field, preferred or equivalent work experience.
• 4-8 years of analytical laboratory experience performing analyses using HPLC, HPLC/MS, GC, UV-Vis, Karl Fisher and dissolution testing to support pharmaceutical stability testing, preferred.
• Experience with 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.
• Experience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g., LabWare) is a plus.
• Experience with identifications of pharmaceutical impurities and degradation products and degradation pathways using LC/MS and other appropriate techniques is a plus.
• Knowledge of cGMP regulation/guidance.
• Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferred.
• 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 prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Strong 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 expert 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.
• Mentors junior team members for analytical instrument uses and data interpretations.
• Reports test data in a form and format that facilitates the use of the data by team members.
• Work with lab manager and other senior staff members of pharmaceutical analysis department, 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 management, 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 preferred.
• Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.

Anticipated salary range: $104,700 - $149,600

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

The application window anticipated to close: 7/11/2025. If interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.