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Analytical Development Principal Research Scientist - Cell & Gene Therapy

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Tuesday, June 11, 2024

Job Description

General Summary:

Vertex pharmaceuticals is seeking a principal scientist to join our CMC analytical development team in our cell and gene therapy organization. We are looking for a highly motivate and experienced technical leader to advance our molecular biology characterization capabilities. The successful candidate will lead a team of scientists and be accountable to establish, advance and qualify new methodologies in DNA and RNA analysis of cellular based product. This position is expected to provide key technical leadership in leading all nucleic acid based method development and qualifications of our cellular products. Methodologies include but not limited to genomic testing, epigenomic analysis, RNA transcriptomics analysis at both bulk and single cell level. Experience in PCR and NGS sequencing is a must. This position requires strong knowledge in developing and qualifying robust analytical methods that can be successfully transferred to QC labs for product release testing. The individual in this role will collaborate closely with research, process development, manufacturing, regulatory and quality to develop and innovate Vertex next generation CT products.

Key responsibilities:

  • Provide strong expertise in genetic analysis of cellular products
  • Provide strong expertise in applying molecular biology tools in developing product characterization package for cellular products
  • Provide strong leadership in analytical method development under CMC regulations
  • Lead a high performing team of analytical scientists in delivering Vertex aspiration goals. Recruit, mentor and develop talents.
  • Strong expertise in experimental design, DNA and RNA sequencing techniques
  • Contribute to design analytical strategy of Cellular products
  • Author CMC section of regulatory filings
  • Collaborate with research and process development department to develop fit for purpose analytical methods to support manufacture process development.
  • Collaborate with quality to develop and qualify analytical methods for product release and stability testing.

Required qualifications:

  • Ph.D. (or equivalent) in analytical chemistry, biochemistry, molecular biology with DNA and RNA sequencing expertise, and 5-8 years' experience in biopharmaceutical industry
  • M.S. (or equivalent) in analytical chemistry, biochemistry, molecular biology with DNA and RNA sequencing expertise, and 8-10 years' experience in biopharmaceutical industry
  • Experience in analytical development in gene or cell therapies, or biologics
  • Experience in a broad variety of analytical techniques
  • Excellent problem solving skills
  • Excellent communication skills to communicate across multiple functional areas

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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 ApplicationAssistance@vrtx.com.