Scientist III, Pharmaceutical Analyst

Cardinal Health; Mansfield; On-site; USD 104,000 - 150,000; Full time

Job summary

A leading company seeks a Scientist III in Pharmaceutical Analysis at their Mansfield location. The role demands expertise in analytical testing and regulatory compliance, focusing on pharmaceutical stability. Candidates should have a Bachelor's degree in Chemistry and 4-8 years of relevant laboratory experience. Competitive salary and comprehensive benefits are offered.

Benefits

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSAs)

Disability coverage

Paid parental leave

Work-Life resources

Qualifications

• 4-8 years of analytical lab experience preferred.
• Experience with stability programs following ICH guidelines.
• Knowledge of cGMP regulation/guidance required.

Responsibilities

• Produce high quality data for pharmaceutical stability analyses.
• Perform analytical testing and data evaluations.
• Collaborate with cross-functional teams on stability issues.

Skills

Analytical testing

Data analysis

Regulatory compliance

Strong communication

Team collaboration

Education

Bachelor’s degree in chemistry or related field

Tools

HPLC

GC

UV-Vis

Karl Fisher

LIMS

Job description

Social network you want to login/join with:

Scientist III, Pharmaceutical Analyst, Mansfield

col-narrow-left

Client:

Cardinal Health

Location:

Mansfield, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

16adf9162b78

Job Views:

3

Posted:

02.07.2025

Expiry Date:

16.08.2025

col-wide

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, 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 stake holders 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

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.

#LI-MP1

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.

To read and review this privacy notice click here