Principal Research Scientist
CareFusion Corporation - Vernon Hills, IL

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This position would coordinate and manage the chemistry stability studies for product remediation and new product development efforts. In addition, the position would provide analytical chemistry support to facilitate remediation and development of existing or new products.

What is expected of you for success in your role

Demonstrates developed knowledge of respective scientific discipline and standard scientific method and techniques

Understanding of FDA requirements related to stability studies, product development and chemical testing requirements for pharmaceutical products

Understanding of GMP documentation requirements

Excellent scientific writing skills

Ability to multi-task various activities

Monitor the chemical stability studies and ensure that testing is conduct at the required time intervals

Administrate and maintain stability database and environmental monitoring systems

Troubleshoot issues that arise and solve problems

Develop and execute some experimental plans related to solving a chemistry-related issue

Ability to discuss scientific strategies/results and interact with other functional areas, including Regulatory, Manufacturing, and Quality.

Qualifications

Qualifications

Education: MS/BS in Chemistry /Pharmaceutics with related science experience

Experience: 5-10 years experience in pharmaceutical analytical chemistry is essential. Previous experience in coordinating / overseeing chemical stability studies for pharmaceutical products

Work within an FDA regulated environment and familiarity with GMP documentation requirements

Familiarity with software for tracking/management of stability studies

Knowledge of the stability testing requirements for pharmaceutical products in major global markets (i.e. US, Europe)

Experience with wet-chemistry testing techniques (i.e. pH, GC, HPLC)

Previous experience with interpretation of stability results and writing scientific stability protocols / reports

Familiarity with method development and method validation

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

  • LI-CW1
Requisition ID

:

130501A0

CareFusion Corporation - 9 months ago - save job - block
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