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- Tasks: Lead a team in managing pharmaceutical stability testing and ensure compliance with regulatory standards.
- Company: Join Cardinal Health, a leader in healthcare solutions dedicated to improving patient outcomes.
- Benefits: Enjoy flexible work options, health coverage, paid time off, and a supportive work-life balance.
- Why this job: Be part of a cutting-edge lab and make a real impact on pharmaceutical safety and quality.
- Qualifications: Bachelor's or Master's in chemistry; 8-12 years in a regulated lab preferred.
- Other info: Diversity is celebrated here; all backgrounds are encouraged to apply!
The predicted salary is between 110000 - 160000 £ per year.
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Manager, Pharmaceutical Analyst, Mansfield
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Client:
Cardinal Health
Location:
Mansfield, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
94172abf8cfa
Job Views:
11
Posted:
12.07.2025
Expiry Date:
26.08.2025
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Job Description:
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
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
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
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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Manager, Pharmaceutical Analyst employer: Cardinal Health
Contact Detail:
Cardinal Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Pharmaceutical Analyst
✨Tip Number 1
Familiarise yourself with the latest ICH and FDA guidelines related to pharmaceutical stability testing. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in GMP/GLP environments. Attend relevant conferences or webinars to make connections that could lead to referrals or insider information about the role.
✨Tip Number 3
Prepare to discuss your leadership experiences in managing analytical teams. Be ready to share specific examples of how you've driven projects to improve processes or resolve issues in a laboratory setting.
✨Tip Number 4
Research Cardinal Health's recent projects and initiatives in the pharmaceutical sector. Being knowledgeable about their work will allow you to tailor your discussions and show genuine interest in contributing to their goals.
We think you need these skills to ace Manager, Pharmaceutical Analyst
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in analytical chemistry and stability testing. Emphasise any leadership roles you've held, especially in a GMP/GLP environment, as this is crucial for the Manager position.
Craft a Strong Cover Letter: In your cover letter, express your passion for pharmaceutical stability testing and your understanding of regulatory requirements like ICH and FDA. Mention specific achievements that demonstrate your ability to manage teams and projects effectively.
Highlight Relevant Skills: Clearly outline your technical skills related to HPLC, GC, and other analytical methods mentioned in the job description. Include any experience with quality management systems and LIMS, as these are important for the role.
Showcase Leadership Experience: Since the role involves managing a team, provide examples of how you've successfully led teams in the past. Discuss your approach to mentoring and developing team members, as well as how you handle compliance and quality assurance.
How to prepare for a job interview at Cardinal Health
✨Understand the Regulatory Landscape
Familiarise yourself with ICH, USP, and FDA guidelines as they relate to pharmaceutical stability testing. Being able to discuss these regulations confidently will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Experience
Prepare examples of how you've successfully managed teams in a laboratory setting. Highlight your experience in leading analytical chemists and any initiatives you've implemented to improve lab operations.
✨Discuss Analytical Techniques
Be ready to talk about your hands-on experience with analytical methods such as HPLC, GC, and UV-Vis. Providing specific examples of how you've used these techniques in past roles will show your technical proficiency.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle Out of Specification (OOS) results or manage compliance issues. Think through your problem-solving strategies and be prepared to share relevant experiences.
