Senior Scientist, Quality Control - Remote

Overview

This position is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy innovation in ophthalmology. As a Senior Scientist of Quality Control (QC), you will play a critical role in accomplishing our mission.

In Short

• Support QC deliverables for small molecule drug substance development in late-stage clinical development
• Review of outsourced GMP work including method validation, lot release, reference standard program and stability testing
• Ensure all project team deliverables are met for outsourced QC work
• Interface with and build strong collaborative relationships with external and internal stakeholders
• Independently resolve technical issues and escalate challenges to management
• Ensure compliance within QC by monitoring test methods and QC analytical data
• Review and approve deviations and laboratory investigations
• Maintain flexibility as is phase appropriate
• Other duties as assigned

Requirements

• 4+ years experience in Quality Control with a Master of Science or 7+ years with a Bachelor’s of Science
• Experience with small molecule method validations and USP method verification
• Excellent knowledge of cGMP requirements and relevant guidelines
• Experience reviewing analytical test results and solving technical problems
• Ability to identify risks associated with method qualifications
• Demonstrated expertise in analytical method lifecycle management
• Experience managing QC related deviations and change controls preferred
• Small molecule experience required

Benefits

• Full health insurance for employees and their families
• Competitive compensation packages
• Paid parking and subsidized commuter passes
• In-office catered lunches and team events
• Community projects and bonding activities