Director of Small Molecule Analytical Development

1 week ago


San Mateo, California, United States Gilead Sciences Full time
Job Description

Gilead Sciences is seeking a highly experienced and skilled Director to lead our Small Molecule Analytical Development team. As a key member of our Pharmaceutical R&D organization, you will be responsible for shaping the development strategy for analytical methods, implementing methodologies according to the analytical control strategy, and data collection for regulatory submissions to support small molecule candidate progression from discovery to marketing application approval.

Key Responsibilities:
  • Lead and develop analytical technical strategies, methods, and technologies to ensure the successful progression of small molecule assets from nomination through marketing application and commercial launch.
  • Directly manage multiple technical development teams and resources, including talent strategy, leadership, and development for scientific staff.
  • Provide technical scientific expertise to CMC analytical project strategy groups and decision-making processes, making difficult scientific decisions to meet changing business needs.
  • Champion scientific innovation and technology to enable analytical method development, seeking opportunities to expand and develop capabilities to support project and departmental goals.
  • Collaborate closely with Analytical Project Strategy team, forming cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control, and Manufacturing Operations.
Requirements:
  • PhD in Chemistry, Analytical Chemistry, Chemical Engineering, or closely related discipline with 8+ years of experience in the pharmaceutical and/or biotechnology industry.
  • Leadership experience leading large and highly technical organizations, with expertise in small molecule analytical development and CMC development.
  • Demonstrated ability in identifying and crafting technical and innovations strategies, staying ahead of shifting trends in the industry.
  • Strong understanding of cGMP and global regulatory requirements, with proven capability to solve critical quality, regulatory, and scientific problems.


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