Scientist II Pharmaceutical Analyst

Cardinal Health-posted 3 months ago

$90,200 - $128,700/Yr

Full-time • Mid Level

Mansfield, MA

Merchant Wholesalers, Nondurable Goods

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The Chemistry Services Center at Cardinal Health performs laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products. This center is part of the Quality, Regulatory & Medical Affairs (QRMA) Scientific Services. The Chemistry Services Center utilizes specialized instruments to conduct Assay and impurity/degradant tests for the stability program of solid dose pharmaceuticals. This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.

Produce high quality data for pharmaceutical stability analyses.
Perform data compilation, review, evaluation and trend analysis on data as applicable.
Conduct analytical testing on stability samples using techniques like HPLC, GC, UV-Vis, Karl Fisher and dissolution testing.
Ensure accuracy and precision of analytical methods by adhering to established quality control procedures.
Conduct all stability testing according to cGMP principles.
Perform analytical method verification, validation and analytical method transfer protocols following regulatory requirements (ICH, USP and FDA).
Investigate Out of Specification (OOS) test results as needed following FDA guidelines.
Maintain compliance with relevant regulatory requirements related to stability studies and data documentation.
Communicate stability data findings to stakeholders through reports.

Bachelor's degree in chemistry or a related scientific field, preferred or equivalent work experience.
2-4 years of analytical laboratory experience performing analyses using HPLC, GC, UV-Vis, Karl Fisher and dissolution testing.
Experience with commercial stability programs following ICH guidelines.
Experience with analytical method verification and validation following regulatory guidelines.
Experience with analytical method transfer following regulatory requirements such as USP.
Experience with investigations of Out of Specification (OOS) per FDA guidelines.
Knowledge of cGMP regulation/guidance.
Experience with pharmaceutical stability test analysis software and LIMS systems for data management.
Experience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g., LabWare) is a plus.
Proficient in the use of instrumental data systems, including data acquisition, analysis and processing (e.g., Waters' Empower software and Mettler Toledo's Labx).
Ability to convey recommendations, data, observations, results, and problems accurately and effectively.
Ability to handle multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Good communication and interpersonal skills.
Ability to operate independently with minimal guidance and supervision.

Experience with data chromatography acquisition software such as Waters Empower.
Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile.
Experience with Laboratory Information Management System (LIMS), such as LabWare.
Possesses working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing.
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

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.

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Scientist II Pharmaceutical Analyst

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