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
As a Senior Scientist, Analytical Development , you'll play a key role in advancing innovative biologic therapies from discovery through early clinical development, helping bring potential new medicines to patients. In this highly collaborative role, you'll drive analytical development strategies for biologic drug substance and drug product, including molecular characterization, analytical method development, control strategy design, and regulatory support. Working closely with scientists and cross-functional partners across Research, Development, and Manufacturing, you'll tackle complex scientific challenges, advance analytical innovation, and support the development of novel therapies. This is an opportunity to apply your expertise, shape key development decisions, and contribute to a team united by a shared purpose: improving lives through transformative medicines.
This position is based in Foster City, CA, and requires onsite work five days per week.
As a Senior Scientist, Analytical Development at Gilead you will...
Key Responsibilities:
Lead analytical activities for pre-pivotal Phase I and Phase II biologic molecules.
Identify molecule-specific critical quality attributes and propose and justify analytical control strategies for biologic drug substance and drug product.
Author relevant sections of regulatory submissions for biologic drug substance and drug product.
Develop analytical methods for molecule characterization and release testing.
Author method development reports, test procedures, validation protocols, and validation reports.
Oversee internal and outsourced testing, provide guidance on data generation and data integrity, and ensure compliance and analytical excellence at contract organizations.
Proactively evaluate and implement state-of-the-art technologies and automation to drive innovation in analytical development and testing.
Build and maintain strong relationships with key stakeholders and provide technical and strategic input to colleagues across Research, Clinical Development, Clinical Supply Management, and Program Strategy.
Provide technical support for internal and external current Good Manufacturing Practice (cGMP) manufacturing operations.
Present research findings and recommendations to senior staff; prepare research reports and peer-reviewed manuscripts; and author or contribute to investigational new drug applications and patent filings.
Basic Qualifications:
Bachelor’s degree and 8+ years of relevant experience
OR
Master’s degree and 6+ years of relevant experience
OR
PhD and 0+ years of relevant experience
Preferred Qualifications:
Biologics-relevant analytical development experience in the biotechnology or pharmaceutical industry.
Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and Phase I investigational new drug…