Study Manager I, Extractable and Leachable

Job description

The Study Manager I, E&L will manage and coordinate projects for extractable and leachable (E&L) testing, including writing and reviewing study protocols and reports. Review testing results and compliance with quality criteria in accordance with cGMP. Write/review study reports; Solve questions and comments of the reports from the clients. Design the E&L studies and write/review study protocols. Work as a technical contact to coordinate extractable and leachable (E&L) projects with clients.

Arrange and follow the projects; communicate promptly to solve technical problems as needed.

Qualifications

• Bachelor’s degree in Chemistry or related science. 2 years of Extractable and Leachables (E&L) project experience with protocol and report writing experience
• Knowledge of HPLC/MS and/or GC/MS and/or ICP/MS analytical instrumentation
• Excellent oral and written communication skills including grammar and composition; Familiar with the common MS Office applications.

Ability to work well with people of diverse backgrounds. Proven project management skills and a strong attention to detail Have excellent interpersonal skills. Previous GMP experience