Senior Scientist, Analytical Development Lead

3 days ago

Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time
Job Summary:

The Senior Scientist, Analytical Development will lead the analytical development activities of Ultragenyx pipeline projects, including monoclonal antibodies, proteins, and other therapeutic modalities.

Key Responsibilities:
  • Method Development and Qualification: Lead the development and qualification of physical chemical analytical methods for in-process, drug substance and drug product characterization, release, and stability testing.
  • Method Transfers: Manage analytical method transfers to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) for clinical phase GMP testing, and support process technology transfer to cGMP CMOs.
  • Collaboration and Communication: Work closely with team members in analytical development and quality control, as well as other functions such as Manufacturing, CMC team, Project Development and Regulatory, to ensure the timely development, validation, testing and release of materials to support clinical activities.
  • Regulatory Submissions: Author and review protocols, technical reports, method SOPs, method qualification documents, analytical sections of IND and BLA/MAA regulatory submissions.
  • Investigations and Experiments: Contribute to laboratory and manufacturing investigations, develop and execute experiments in the laboratory as needed.
  • CMC Assessment: Support CMC assessment of in-licensing opportunities and technology opportunities.
Requirements:
  • Education and Experience: PhD/MS/BS in chemistry, biochemistry, molecular biology, or chemical engineering with analytical development experience in the Pharmaceutical or Biotechnology industry; PhD a minimum of 5-8 years; MS a minimum of 8-10 years; or BA/BS a minimum of 10-12 years related experience.
  • Method Development Experience: Hands-on experience in analytical method development for biologics including HPLC, CE and/or mass spectrometry-based methods.
  • Product Characterization: Solid understanding of product characterization of biologics, including monoclonal antibodies and proteins.
  • Regulatory Knowledge: Thorough technical understanding of early and late-stage development of biologics products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
  • Management Experience: Management experience of internal lab, contract manufacturing sites, and contract analytical labs.
  • Communication Skills: Excellent written and verbal communication skills; Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.

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