Job Type: Contract
Job Length: 1 Year (Renewable)
Job ID: 32735
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
• Ability to conduct various chemistry studies to support existing or new products
• Develop and execute some experimental plans related to solving a chemistry-related issue
• Troubleshoot issues that arise and solve problems
• 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
• Ability to discuss scientific strategies/results and interact with other functional areas, including Regulatory, Manufacturing, and Quality.
• Education: MS/BS in Chemistry /Pharmaceutics with related science experience
• Experience: At least 5 years experience in pharmaceutical analytical chemistry is essential.
• Experience with wet-chemistry testing techniques (i.e. pH, GC, HPLC)
• Familiarity with method development and method validation
• Work within an FDA regulated environment and familiarity with GMP documentation requirements
• Knowledge of the stability testing requirements for pharmaceutical products in major global markets (i.e. US, Europe)
• Previous experience with interpretation of scientific results and writing scientific protocols / reports
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form