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This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.

 

Job Summary:The Scientist, Analytical Science & Technology role will provide expertise in assay development, validation, and end-to-end analytical support for commercial manufacturing and critical component release within the Cell and Gene Therapy (CGT) portfolio.

Key Responsibilities:

  • Independently or collaboratively lead analytical lifecycle activities including method development, validation, and method transfer
  • Author and/or review technical documentation such as standard operating procedures (SOPs), study protocols, and technical reports
  • Serve as a Subject Matter Expert (SME) in troubleshooting and out-of-specification (OOS) investigations during release and/or stability testing
  • Provide SME input for deviations, corrective and preventive actions (CAPAs), and change control processes
  • Perform data trending and analytical assessments
  • Participate in internal and external meetings as a representative of the ASAT function

Knowledge and Skills:

  • Strong technical writing skills
  • Hands-on experience and deep understanding of molecular and/or cell biology
  • Experience in cell and gene therapy is preferred
  • Familiarity with next-generation sequencing (NGS) technologies is a plus
  • Knowledge of ICH guidelines, regulatory requirements, and strong understanding of current Good Manufacturing Practices (cGMP)
  • Experience providing analytical support for late-stage or commercial biological products in a GMP environment
  • Ability to manage multiple priorities and meet project timelines while maintaining flexibility and efficiency
  • Proven ability to collaborate effectively with internal teams and external partners
  • Experience using statistical tools such as JMP is a plus

Education and Experience:

  • Bachelor’s degree or higher in Biology, Biochemistry, Analytical Chemistry, or a related field
  • Minimum of 8 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
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