Scientist, FPD

Gilead Sciences•Foster City, CA

About The Position

The Scientist, Biologics Pivotal Formulation and Process Development role is part of a collaborative, interdisciplinary CMC development team that uses state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate brings relevant technical expertise, contributes to functional strategies, and advances innovation in formulation and drug product process development. The position offers opportunities to develop new skills, experiences, and professional relationships in a fast-paced, resource-rich environment. The role includes designing and executing formulation and drug product process development work, conducting hypothesis-driven research, applying protein characterization insights to development decisions, and authoring technical and regulatory documents. The scientist collaborates with internal and external stakeholders and contributes to departmental and cross-functional initiatives. The posting also describes people-leader accountabilities related to inclusion, talent development, and empowering teams.

Requirements

  • Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0 or more years of experience; or a master's degree with 4 or more years of experience; or a bachelor's degree with 6 or more years of experience.
  • Hands-on laboratory experience.

Nice To Haves

  • 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 biologic modalities.
  • Solid understanding of protein characterization and structure-property relationships, including integrating analytical and biophysical data to assess protein stability.
  • Ability to conduct independent, hypothesis-driven research, including defining scientific questions, designing appropriate studies, critically analyzing data, and updating hypotheses and experimental plans based on outcomes.
  • Record of publications and external presentations, together with a demonstrated desire to innovate through research.

Responsibilities

  • Design and execute formulation and drug product process development work packages, including formulation development, drug product manufacturing process development, and clinical in-use evaluations.
  • Drive innovation and expand technical expertise; influence internal and external audiences through publications, presentations, and participation in industry collaborations.
  • Demonstrate understanding of analytical, biophysical characterization, and process development techniques; introduce new capabilities and lead by example in laboratory execution.
  • Conduct independent, hypothesis-driven research by formulating hypotheses, designing and executing fit-for-purpose studies, interpreting results, and refining hypotheses in light of emerging data.
  • Apply protein characterization and structure-property relationship insights to formulation and drug product development decisions.
  • Maintain data integrity and good documentation practices in data and report generation, and critically review internal and external documentation.
  • Author technical documents, including protocols, reports, and regulatory dossier content, for internal and external audiences.
  • Collaborate with internal and external stakeholders and contribute to project team discussions and decision-making.
  • Support departmental initiatives and cross-functional projects that advance business process excellence and scientific innovation.
  • As a people leader, create inclusion, develop talent through coaching and feedback, and empower teams by aligning goals, holding teams accountable, removing barriers, and connecting them to the broader organization.

Benefits

  • Discretionary annual bonus may be available.
  • Discretionary stock-based long-term incentives may be available; eligibility may vary by role.
  • Paid time off.
  • Company-sponsored medical, dental, vision, and life insurance plans.
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