Manager, Pharmaceutical Analyst

Chemistry Services Center Role

Chemistry Services Center performs 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

• Manage the day-to-day operations and quality of the Pharmaceutical Stability Department.
• Oversight of Analytical Chemists and lab personnel.
• Potential candidates will have the unique opportunity to lead the creation of brand-new stability testing lab.
• Participate in laboratory budgets planning.
• Serves as a department representative in cross-functional working teams and/or working with outside customers to meet stability testing needs.
• 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.
• 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.

Qualifications

• Bachelor's degree or Master's degree in chemistry, or a related science degree, preferred or relevant work experience.
• 8 12 years' experience in a regulated GMP/GLP analytical laboratory, preferred.
• 4 years leading an Analytical Chemistry Pharmaceutical Stability Lab a Plus.
• 5+ 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, preferred.
• Experience with management of stability programs following ICH guidelines and leading an analytical chemist team, preferred.
• Experience with analytical method verification and validation, and method transfer following regulatory guidelines, preferred.
• Experience 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, preferred.
• Knowledge of cGMP regulation/guidance, preferred.
• Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferred.
• Knowledge of instrumental data systems, including data acquisition, analysis and processing (e.g., Waters' Empower software and Mettler Toledo's Labx) preferred.
• 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.
• 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.
• Partner with EH&S to ensure safety within the laboratory for all lab personnel.

Anticipated salary range: $136,100 - $194,700

Bonus eligible: Yes

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

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.