Associate Scientist, Physical Properties

About the Role

The Associate Scientist, Physical Properties is primarily responsible for supporting GxP activities within our R&D Operations laboratory. This individual will execute routine test methods, support equipment qualification activities, and assist in the integration of new equipment into existing test methods with the support of subject matter experts within the physical properties lab. Additional activities include data analyses including the identification of data trends, reporting observations, supporting project teams, and providing method development support for methods utilized in R&D.

Key Responsibilities

• Testing in accordance with procedures for clinical samples, stability protocols, equipment qualification, and test method validation requirements (70%).
• Utilizes tools to track and trend method performance and begins to identify key opportunities for improvement. Applies trend results to help prioritize the resolution of equipment, systems, or processes to prevent recurrence (10%).
• Represents the physical properties team in conjunction with senior team members for multi-departmental meetings and project teams, as needed (10%).
• Performs other related duties as assigned by management (10%).

Requirements & Tech Stack

• GxP requirements
• ICH Q2
• ISO 18369 guidance in support of contact lens testing
• Wet chemistry techniques (gravimetric water content)
• Spectroscopy (UV Vis, Raman, FTIR)
• Wettability (using tensiometer)
• Oxygen permeability (polarographic method)
• Refractive index (abbe refractometer)
• Mechanical properties (tensile testing)

Qualifications

• Bachelor’s Degree - Science/Engineering
• 0-3 years industry experience working in medical device, pharmaceutical, or other testing.
• Awareness of ISO 18369 guidance documents / ICH Q2 / FDA regulatory requirements.
• Excellent organizational, interpersonal, written, and oral communication skills.
• Ability to organize and analyze data.
• Ability to handle multiple projects/methods simultaneously.
• Familitary with GxP requirements, ICH Q2, and ISO 18369 guidance in support of contact lens testing are desired.
• The ability to work closely with project teams and collaborate with support functions to meet or exceed goals is critical to ensure success.
• Must follow laboratory safety procedures.