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, the Chemistry Service Center will 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 

Plan and schedule work according to laboratory needs.  Participate in laboratory budgets planning, including ordering equipment and supplies, ordering consumables, and tracking costs Serves as a department representative in cross-functional working teams and/or working with outside customers to meet stability testing needs Ensure all stability testing is conducted according to cGMP principles.  Review analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).  Participate in investigations of Out of Specification (OOS) test results as needed follow FDA guidelines. Manage and maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to stability studies and data documentation.  Maintain a clean, safe work environment, comply with safety policies, and dispose of waste according to local, state, and federal regulations. Ensure that the laboratory equipment and instruments are in good working conditions to perform analytical testing and minimize down time. Collaborate with cross-functional teams to discuss stability concerns and address issues.  Monitor, track, and publish metrics and react to key process performance indicators (KPI). Identifies areas for improvement and drives projects to implement solutions. Train and mentor chemists in the department for continued improvement in the areas of technical knowledge, productivities and regulations. 

 

Qualifications 

Bachelor’s degree in chemistry or a related scientific field, preferred or relevant work experience4-8 years of experience in pharmaceutical / biopharmaceutical analyses5+ years of analytical laboratory experience performing analyses HPLC, HPLC/MS, GC, UV-Vis, Karl Fisher and dissolution testing to support pharmaceutical drug product development and registration, preferredExperience with management of stability programs following ICH guidelines and leading an analytical chemist team, preferredExperience with analytical method verification and validation, and method transfer following regulatory guidelines, preferredExperience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g., LabWare) is a plus. Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferredExperience with statistical software and its application to support commercial stability, preferredKnowledge of cGMP regulation/guidance. Ensure all records adhere to cGMP/GDP expectations, preferred Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferredKnowledge of instrumental data systems, including data acquisition, analysis and processing (e.g., Waters’ Empower software and Mettler Toledo’s Labx) preferred. Strong project management skills. Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility. Strong communication (both oral and written) and interpersonal skills.   

 

What is expected of you and others at this level 

Manage pharmaceutical stability programs with high quality data and provides expert interpretations of analyses. Ability to manage a team of analytical chemists to produce high quality analytical tests results within tight timelines and in a highly regulated environment. Work with other lab managers and senior staff members, provide guidance for development of 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.  Review analytical method transfer and validation/verification protocols and reports.  Possesses significant working knowledge of USP, FDA and ISO regulatory requirements as applicable to pharmaceutical stability testing. Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures. 

Anticipated salary range: $106,300 - $151,900

Bonus eligible: no

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programs

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.

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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.

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