Study Manager I, Extractable and Leachable

About the role

As a Study Manager I, E&L at SGS, you will manage and coordinate projects for extractable and leachable (E&L) testing. This includes writing and reviewing study protocols and reports, reviewing testing results, and ensuring compliance with quality criteria in accordance with cGMP.

Responsibilities

• Write and review study protocols and reports for E&L testing.
• Review testing results and ensure compliance with quality criteria under cGMP.
• Address questions and comments on reports from clients.
• Design E&L studies and serve as the technical contact for clients.
• Coordinate E&L projects, arrange and track progress, and promptly resolve technical issues.
• Communicate effectively to solve technical problems as they arise.

Requirements

• Bachelor’s degree in Chemistry or a related scientific field.
• 2 years of Extractable and Leachables (E&L) project experience, including protocol and report writing.
• Knowledge of HPLC/MS, GC/MS, and/or ICP/MS analytical instrumentation.
• Excellent oral and written communication skills, including grammar and composition.
• Proficiency with common MS Office applications.
• Ability to work effectively with people from diverse backgrounds.
• Proven project management skills and strong attention to detail.
• Excellent interpersonal skills.
• Previous GMP experience.

Benefits

• Health: Medical, dental, and vision insurance; life insurance; employee wellness programs.
• Wealth: Competitive pay; 401(k) with company match (immediate vesting upon enrollment); employee referral program; annual bonus target.
• Happiness & Professional Growth: Online training courses; virtual and classroom development experiences; tuition reimbursement program.
• Work-Life Balance: Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time).