Senior Associate Scientist, Purification Process Development

Job Description

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 Senior Associate Scientist, Purification Process Development (Pre-Pivotal) will plan and execute purification process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also plan and execute laboratory experimentation for purification process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.

Key Responsibilities

• Establish and maintain a state-of-the-art purification lab that enables rapid new biologics entities manufacturability assessment, purification process development and scaleup.
• Contribute to experimental design. Plan and execute purification process development laboratory studies independently. Support process scaleup and implementation in internal and external GMP facilities.
• Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author and review experimental protocols and reports.
• Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Provide oversight at internal and external manufacturing facilities as person-in-plant. Provide technical support for manufacturing atypical event investigations.
• Support non-GMP pilot lab operations. Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
• Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
• Lead purific