Principal Scientist, Biologics Pre-Pivotal Formulation & Process Development

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

The Principal Scientist, 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 successful candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product lead 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.

• Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions

• Represent FPD function by managing one or more critical component of cross-functional team and work collaboratively and effectively to advance project strategy and objectives

• Manage one or more long-term critical components of a cross-functional project with limited supervision.

• Leads or contributes to initiatives or evaluation of new technologies in support of optimizing FPD work practices and/or achieving departmental goals.

• Influence internal and external stakeholders through publications, presentations, and representation in industrial collaborations by driving innovation and continuously growing and sharing technical expertise.

• Support initiative teams to drive business process excellence, improve research and development procedures, and advance scientific innovation. 

• Participate in the interviewing, assessment, onboarding, and coaching new team members 

• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.

Qualifications: 

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related fields with a minimum of 5+ years of industrial experience, OR M.S. with a minimum of 8+ years of industrial experience, OR B.S. with a minimum of 10+ years of industrial experience.

• Experience should be in biologics CMC development.

• Extensive experience with formulation development, Drug Product process development, and clinical in-use evaluation of monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats

• Broad experience with early-stage development activities including authoring and submission of INDs and IMPDs.

• 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.

• Experience and expertise in lyophilization cycle development, development of viral vectors and vaccines, GMP drug product fill and finish, lab automation and data science are highly desired.

• People leading experience is strongly desired. 

• Experience working with contract organizations is highly preferred.