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Senior Manager, Medical Device Analytical Development

Company: myGwork
Location: Providence
Posted on: January 23, 2023

Job Description:

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. FTIR, DSC, TGA, viscosity, chromatography, structural elucidation, visual inspection, material stress/strain characteristics, and mechanical tests for hardness)
  • Lead a team of 2-4 members in the execution of key project activities.
  • Enable transfer of assays to QC and provide SME to support for assay qualification, author transfer/qualification protocols and reports
  • Execute test methods in support of device Process Development and Quality activities
  • Troubleshoot, optimize, and trend assay and process performance
  • Management of activities at third party vendors/CRO's
  • Report on project progress, write analytical development protocols and reports, provide recommendations to management
  • Identify, qualify, and manage analytical reagents as per regulatory standards
  • 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.
  • Establish reference standard materials as required to support assay validation.
  • Auhtor regulatory submission documents with detailed method s and data analysis.
  • Maintain excellent written documentation and review (e.g. lab notebook and test forms).
  • Ensure the accuracy and integrity of analytical data generated within the team. Education Requirements: PhD in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline with 5+ years of relevant pharmaceutical or medical device industry experience in post-graduation assay/analytical development. Or Masters in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline and 10+ years of relevant pharmaceutical or medical device industry experience in post-graduation assay/analytical development. Skills Required:
    • Advanced knowledge of more than one of the following methods or area: FTIR, TGA, DSC, porosity/flux, chromatography, structural elucidation, microscopy and mechanical material characterization (e.g. hardness, viscosity, stress/strain curves).
    • Project and people management experience in relevant area and ability to multi-task to manage competing project goals.
    • Expertise in development and validation of analytical methods.
    • Demonstrated leadership with method qualification and transfer between groups, sites or a CRO/CMO
    • Strong skills for collaboration across teams for technical and business development activities
    • Demonstrated ability to use literature to design proof of concept experiments for new assays
    • Proven experience with regulatory agency submissions and correspondence
    • Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
    • Experience with sample management and electronic documentation systems in the GMP environment #LI-JS1 Company Information Vertex 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. This employer is a corporate member of
      myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
      students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, Providence , Senior Manager, Medical Device Analytical Development, Executive , Providence, Rhode Island

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