Sr Associate Scientist, FPD

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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pre-Pivotal Formulation and Process Development, as a Senior Associate Scientist. The successful candidate will contribute to the development of formulation and drug product processes for innovative molecules to support toxicology and early clinical stage studies. The candidate will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment. The ideal candidate is expected to be action oriented with high expectations of themselves and others and should possess good verbal and written communication and interpersonal skills. 

Responsibilities:  

·         Design and successfully execute experiments and activities to support formulation and drug process development, including molecular assessment, First-in-Human formulation development, Drug Product manufacturing process development, and clinical in-use evaluations. 

·         Demonstrate understanding of analytical, biophysical characterization, and process development techniques; lead by example for lab executions. 

·         Clearly, timely, and accurately document data in appropriate repositories such as lab notebooks, reports, protocols, etc. following good documentation practices.

·         Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and external audience. 

·         Effectively collaborate with both internal and external stakeholders in project meetings. 

·         Analyze data and draft conclusions before discussing with manager or supervisor. 

·         Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings. 

·         Fully embrace a lean-agile mindset, matrix working environment, and continuous improvement.  

·         Help support key project or department stakeholders as needed to ensure that company objects are met. 

·         Support team initiatives to drive business process excellence, scientific innovation, laboratory and work safety, etc.    

Basic Qualifications:  

·         MS/MA with 3+ years, or BS/BA with 5+ years of industrial experience in biologics CMC development. 

·