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Analytical Development Principal Research Scientist

Semma Therapeutics

Semma Therapeutics

Providence, RI, USA
Posted on Tuesday, February 6, 2024

Job Description

General Summary:

In June 2019, Vertex announced the establishment of a new research focus in development and clinical manufacturing for cell and genetic therapies. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

The Platform & Enabling Technologies group within VCGT Device Analytical Development is focused on proactively identifying platform technologies to improve Device characterization and process understanding. The Principal Scientist will lead a team of scientists to search out new technologies, obtain proof of concept for our specific application, and develop an implementation strategy.

Key Duties and Responsibilities:

  • Identify new platform technologies, obtain proof of concept for Device or incoming materials application, coordinate with partner groups to develop an implementation strategy within the clinical production space.
  • Lead a team of 2-3 members and facilitate additional actions within Device AD to identify platform technologies and implement them into the clinical Device program.
  • Perform comparability assessments with new and existing test methods
  • Spearhead the advanced vision systems development (automated visual inspection)
  • Extend the cross-functional partnerships and impact of Device analytical development across Vertex
  • Increase external recognition of Vertex for innovation within Analytical Development
  • Build and maintain strong relationships with vendors and academia focused on platform technologies
  • Management of activities at third party vendors/CRO’s to drive completion.
  • Generate project timelines, report on progress, write analytical development reports and provide recommendations to the team.
  • Maintain excellent written documentation and reviews (e.g. lab notebook and test forms).
  • Ensure the accuracy and integrity of analytical data generated within the team.

Knowledge and Skills:

  • Advanced knowledge and hands on experience in at least two of the following areas of characterization: Materials science, mechanical testing, porosity/flux, microscopy, spectroscopy, image analysis.

  • Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
  • Demonstrated ability to use literature to design proof of concept experiments for new assays
  • Proven leadership in analytical method innovation through publications or clinical production implementation
  • Track record of using multiple analytical tools to solve complex problems.
  • Project and people management experience in relevant area and ability to multi-task to manage competing project goals to drive on-time completion.
  • Understanding of regulatory requirements for medical devices
  • Expertise in development, validation, and transfer of analytical methods.
  • Preferred hands-on experience of experience in image segmentation and classification technology development and evaluation.
  • Preferred experience with metrology and smart vision systems.
  • Familiarity with AI/ML algorithm classes

Education and Experience:

  • 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 8+ years of relevant pharmaceutical or medical device industry experience in post-graduation assay/analytical development.

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.

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