Senior Analytical Development Scientist (Medical Devices)

Vertex Pharmaceuticals

Providence (RI)

On-site

USD 56,000 - 59,000

Full time

12 days ago

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

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)