Senior Research Associate, Medical Device Analytical Development

Company: Vertex Pharmaceuticals
Location: Providence
Posted on: May 16, 2022

Job Description:

Job DescriptionGeneral Summary:The Analytical Development Senior Research Associate independently performs complex experimental procedures designed through collaboration with their supervisor. Works collaboratively with the analytical team providing technical support to achieve medical device program goals within established timelines and demonstrates excellent documentation skills. Independently performs troubleshooting as needed. Reports experimental findings and results to the team in an organized and clear manner. Authors method documents, analytical protocols and reports. Contributes to lab organization and efficient lab functioning.Key Duties and Responsibilities:

• Design, execute and analyze studies to develop and qualify test methods, demonstrate technological feasibility and characterize material and assembled device products, employing multiple analytical methods (e.g. Primarily FTIR, DSC, TGA, mechanical tests for hardness, 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
• 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 QC and provide SME support for assay qualification, author transfer/qualification protocols and reports
• Maintain excellent written documentation (e.g. lab notebook and test forms).Knowledge and Skills:
  • Hands-on experience with the following methods: FTIR, TGA, DSC, porosity, and mechanical material characterization (e.g. hardness, viscosity, stress/strain curves) as well as GC/LC method development.
  • Ability to use literature to design proof of concept experiments for assays
  • Prior experience developing and validating analytical methods.
  • Experience with cGMP and/or regulatory requirements
  • Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary teamEducation and Experience:
    • Bachelor's degree (or equivalent degree) in relevant discipline and 4+ years of experience in analytical development program or other analytical support function, or
    • Master's degree (or equivalent degree) in Materials Science, Biomedical Engineering, Analytical Chemistry, Polymer Chemistry or related discipline and 0-2 years of experience in analytical development program or other analytical support function
    • Knowledge and hands on experience with analytical platforms used for characterization of materials and/or medical devices#LI-JS1Company InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Keywords: Vertex Pharmaceuticals, Providence , Senior Research Associate, Medical Device Analytical Development, Healthcare , Providence, Rhode Island