Scientist, FPD

About the Role

The Scientist, Biologics Pivotal Formulation and Process Development role is part of a collaborative and interdisciplinary CMC development team that applies state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovation in formulation and drug product (DP) process development. The individual will have opportunities for growth through the acquisition of new skills, experiences, and professional relationships in a fast-paced, resource-rich environment.

Key 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 continuously expand technical expertise; influence internal and external audiences through publications, presentations, and representation in industry collaborations.
• Demonstrate a strong understanding of analytical, biophysical characterization, and process development techniques; introduce new capabilities; and lead by example in laboratory execution.
• Independently conduct hypothesis-driven research by formulating scientific hypotheses, designing and executing fit-for-purpose studies, interpreting results, and refining hypotheses based on emerging data. Apply protein characterization and structure-property relationship insights to guide formulation and drug product development decisions.
• Fully embrace data integrity and good documentation practices in data and report generation; critically review internal and external documentation.
• Author technical documents, including protocols, reports, and regulatory dossier content, for internal and external audiences.
• Collaborate effectively with internal and external stakeholders and contribute to project team discussions and decision-making.
• Support and contribute to departmental initiatives and cross-functional projects that drive business process excellence and scientific innovation.

Requirements & Tech Stack

• Hands-on laboratory experience is required.
• 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 is strongly desired.
• Solid understanding of protein characterization and structure-property relationships, including the ability to integrate analytical and biophysical data to assess protein stability, is strongly preferred.
• Demonstrated ability to conduct independent, hypothesis-driven research, including defining scientific questions, designing appropriate studies, analyzing data critically, and updating hypotheses and experimental plans based on study outcomes, is preferred.
• A record of publications and external presentations, together with a demonstrated desire to innovate through research, is strongly preferred.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0+ years of experience OR
• 4+ Years with MS OR
• 6+ Years with BS

People Leader Accountabilities

• Create Inclusion: Know the business value of diverse teams, model inclusion, and embed the value of diversity in how teams are managed.
• Develop Talent: Understand employees’ skills, experience, aspirations, and potential; coach on current performance and future potential; ensure employees receive the feedback and insight needed to grow and develop.
• Empower Teams: Connect the team to the organization by aligning goals, purpose, and organizational objectives, holding them accountable, removing barriers, and connecting them to the broader ecosystem.

Salary Range: $146,540.00 - $189,640.00

Note: Actual compensation will vary based on factors including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including company-sponsored medical, dental, vision, and life insurance plans. For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing