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

Vertex Pharmaceuticals; Providence (RI); On-site; USD 56,000 - 59,000; Full time

Job summary

Vertex Pharmaceuticals seeks an Analytical Development professional for its Providence, RI site. Education includes a Master’s in Materials Science, Biomedical Engineering, Analytical Chemistry, Polymer Chemistry, or related field, with 0–2 years of industry assay/analytical development experience, or a Bachelor’s with 2+ years in the field.

Experience with pre-filled syringes or auto injectors is REQUIRED.

Qualifications

• 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.

Responsibilities

• Execute and analyze data from studies to develop and qualify test methods, demonstrate technological feasibility and characterize material and assembled device products.
• Execute test methods in support of device Process Development and Quality activities
• Toubleshoot, optimize, and trend assay performance
• Report on project progress and write analytical development protocols and reports
• Establish design criteria using Design of Experiments and other development tools
• Perform statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods
• Maintain analytical lab instrumentation and manage lab reagents
• Identify and manage analytical reagents per regulatory standards
• Establish reference standard materials to support assay validation
• Ensure accuracy and integrity of analytical data
• Transfer assays to vendors and provide SME support for assay qualification and transfer/qualification protocols
• Maintain written documentation (ELN, lab notebook, test forms)

Skills

Analytical chemistry

Statistical analysis

Design of Experiments

Documentation

Regulatory standards knowledge

Project reporting

Education

Master's in Materials Science

Bachelor's in Chemistry or related field

Tools

DOE software

Job description

Job Description

Key activities:

• 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, provide recommendations to management
• Establish design criteria using Design of Experiments (DOE) and other contemporary development tools
• With manager guidance, 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).

Education:

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.

This is at Vertex's Providence, RI location.

Pay Range

$41-$43/HR