Senior Scientist, Stability

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
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  

As a Senior Scientist, Stability at Gilead you will be vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations for stability.

Focus Areas:

• Manage stability strategy for assigned products. Coordinate and oversee GMP stability studies for clinical and commercial products, ensuring compliance with FDA, ICH, and global regulatory requirements.

• Manage stability study setup and execution, including protocols, storage conditions (ICH long-term, intermediate, accelerated), pull schedules, testing panels, and acceptance criteria.

• Oversee stability sample management, including receipt, labeling verification, controlled storage, chain of custody, and timely sample pulls.

• Monitor stability chamber conditions (temperature/humidity), support maintenance and qualification activities, and manage excursions and related investigations.

• Compile, review, trend, and statistically analyze stability data to identify product risks and support shelf-life assignments, APR/PQRs, and regulatory submissions.

• Maintain stability programs and records in electronic systems.

• Author and review stability sections of regulatory submissions

• Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs.

• Ensure inspection readiness and support internal and external audits.

• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.

• Collaborate cross functionally with Quality Control, Quality Assurance, Analytical Development, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support stability commitments, filings, and health authority responses.

Qualifications:

• Experience with Biologics Quality Control with knowledge of industry best practices and trends for Stability.

• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. 

• Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories. Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation. 

• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. 

• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.

• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. 

• Demonstrated the ability to influence process and outcomes across functions.

Requirements:

• 8+ Years experience with BS in Chemistry, Biochemistry or related field OR

• 6 + Years with MS in Chemistry, Biochemistry or related field