Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development

Job Description

The Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities:

• Design and execute formulation and drug product process development work packages, including molecular assessment, First-in-Human formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
• Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
• Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions
• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentations.
• Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
• Lead initiative teams to drive for business process excellence and scientific innovation.
• May coach direct reports.

Qualifications:

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related fields with 2+ years, M.S. with 8+ years, or B.S. with 10+ years of industrial experience in biologics CMC development.
• Extensive 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; experience of IND filings.
• Hands-on in lab execution and has experience of training junior members.
• Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
• Lyophilization cycle development, GMP drug product fill and finish, lab automation and data science experience and expertise is highly desired.
• People leading experience is strongly desired.
• Experience working with contracted organization is highly preferred.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)