Sr Associate Scientist, Biologics Pivotal Formulation & Process Development

Role Summary

Senior Associate Scientist in Biologics Pivotal Formulation and Process Development at Gilead. Lead and contribute in the development of formulation and drug product processes for innovative molecules to advance medicine into the clinic. The role requires strong collaboration, communication, and a proactive, results-oriented approach in a fast-paced environment.

Responsibilities

• Design and execute experiments to support formulation and drug process development, including formulation screening, process development, and clinical in-use evaluations.
• Demonstrate expertise in analytical and biophysical characterization and drug product process development techniques; provide on-the-job training and guidance to new or less experienced colleagues.
• Clearly, timely, and accurately document study plans and data in lab notebooks and other repositories, following good documentation practices.
• Analyze data, draft conclusions, and discuss findings with managers or supervisors.
• Author technical documents such as memos, protocols, reports, and regulatory dossiers.
• Prepare high quality and data-focused presentations for internal and external audiences.
• Effectively collaborate with internal and external stakeholders in project and strategy meetings.
• Support and/or represent Biologics Pivotal Formulation and Process Development organization on cross-functional teams to advance project strategy and regulatory filings.
• Embrace a lean-agile mindset, matrix working environment, and continuous improvement.
• Support team initiatives to drive business process excellence, scientific innovation, and laboratory/work safety.
• Contribute to the completion of programs, projects, or individual business targets to ensure that company objectives are met.

Qualifications

• Required: Bachelor's degree and 5+ years of relevant experience; OR Master's degree and 3+ years of relevant experience; OR hands-on laboratory experience required.
• Preferred: Relevant industrial experience in biologics CMC development; Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats.

Education

• Bachelor's degree with 5+ years of relevant experience; or Master's degree with 3+ years of relevant experience; hands-on laboratory experience may substitute for formal education as appropriate.