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 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.
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.
Basic 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
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…