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Analytical Development Senior Scientist, Cell and Genetic Therapies

Hampton Research

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

General Summary:

Vertex Cell and Genetic Therapies (VCGT) is seeking a highly motivated, dynamic, and self-driven Senior Research Scientist to join our growing Analytical Development group in Boston, MA. The ideal candidate will have a strong technical expertise in gene therapy or biologics, and a strong background in analytical development. Responsibilities include but not be limited to CRO oversight, analytical method development, qualification and validation, stability studies as well as contributing scientifically to the resolution of analytical development challenges in collaboration with various stakeholders. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.

Key Duties and Responsibilities:

  • Oversee method feasibility, qualification, and validation activities at CROs
  • Executes analytical strategy for release and characterization
  • Manage external and internal stability studies for assigned product/program
  • Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods
  • Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions
  • Interpret results, troubleshoot technical hurdles, perform laboratory investigations, and propose solutions to the team
  • Collaborate effectively across the organization, present internally to project teams, management, and scientific teams
  • Keep accurate and timely records of all experiments

Knowledge and Skills:

  • Understanding of analytical development for biological products (viral vectors, proteins, cells)
  • Conversant in the regulatory guidance for specific types of biological products
  • Strong background in at least two of the following assays: PCR (ddPCR, qPCR), chromatography (HPLC/UPLC, CE), ELISA, microbiological assays, cell-based assays
  • Skilled in efficient study design and demonstrated expertise in writing SOPs, analytical protocols and reports.
  • Demonstrated ability to troubleshoot and resolve issues during method transfer, qualification, and validation
  • Advanced analysis skills to allow understanding of experimental data and the ability to use information gained to inform method and program decisions
  • Ability to multi-task as necessary, managing competing priorities and advancing multiple projects within required timelines
  • Strong communication skills and a willingness to reach out across teams to accomplish program goals
  • Experience with ELN/LIMS systems
  • Demonstrates advanced judgment balancing technical feasibility, opportunity, and impact
  • Demonstrated ability to work cross-functionally to improve communication and make organizational processes more efficient

Education and Experience:

  • Typically requires the following, or the equivalent combination of education and experience: PhD in Biochemistry, Analytical Chemistry, Cell & Molecular Biology or related discipline and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years.

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.