Analytical Development Senior Research Associate, Material/Medical Device Analytical Development (Contract)

Atrium Works • Providence, RI

3d • Onsite

About The Position

This is a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals. The individual selected for this role will be offered the role as an employee of a third-party agency partner. The role involves executing and analyzing data from studies to develop and qualify test methods, demonstrate technological feasibility, and characterize material and assembled device products. This includes employing multiple analytical methods such as Mechanical tests for Pre-filled syringes and Auto injectors, viscosity, and material stress/strain characteristics, as well as chromatography. The role also includes executing test methods in support of device Process Development and Quality activities, troubleshooting, optimizing, and trending assay performance, reporting on project progress, writing analytical development protocols and reports, and providing recommendations to management. Establishing design criteria using Design of Experiments (DOE) and other contemporary development tools, performing statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods, and maintaining analytical lab instrumentation are also key responsibilities. The role requires managing lab reagents, ensuring appropriate preventative maintenance and calibration, identifying, qualifying, and managing analytical reagents as per regulatory standards, and establishing reference standard materials. Ensuring the accuracy and integrity of analytical data, transferring assays to vendors, and providing SME support for assay qualification are also part of the role. Maintaining excellent written documentation, such as in an ELN, lab notebook, and test forms, is essential.

Requirements

• Masters in Materials Science, Biomedical Engineering, Analytical Chemistry, Polymer Chemistry or related discipline with 0-2 years of industry experience in assay/analytical development for materials and medical devices or Bachelors with 2+ years of relevant industry experience.
• Experience with pre-filled syringes or auto injectors NEEDED.

Responsibilities

• Execute and analyze data from studies to develop and qualify test methods.
• Demonstrate technological feasibility and characterize material and assembled device products, employing multiple analytical methods (e.g. Mechanical tests for Pre-filled syringes and Auto injectors, viscosity, and material stress/strain characteristics, as well as chromatography).
• Execute test methods in support of device Process Development and Quality activities.
• Troubleshoot, optimize, and trend assay performance.
• Report on project progress, write analytical development protocols and reports, and provide recommendations to management.
• Establish design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
• Maintain analytical lab instrumentation, manage lab reagents, ensure appropriate preventative maintenance and calibration is carried out.
• Identify, qualify and manage analytical reagents as per regulatory standards.
• Establish reference standard materials as required to support assay validation.
• Ensure the accuracy and integrity of analytical data generated.
• Transfer assays to vendors and provide SME support for assay qualification, author transfer/qualification protocols and reports.
• Maintain excellent written documentation (e.g. ELN, lab notebook and test forms).

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• eligible for overtime pay, in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level