Senior Associate Scientist, Biologics Pilot Lab- Pre-Pivotal Biologics Development

Senior Associate Scientist, Biologics Pilot Lab- Pre-Pivotal Biologics Development – Foster City, CA

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. We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams. 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. Join Gilead and help create possible, together.

Job Description

The Senior Associate Scientist, Pilot Lab Operations will lead and execute pilot scale purification operations to generate materials to support toxicology studies as well as Research Process Development activities. He/She will be responsible for Pilot Lab operation readiness, staff training, innovation and technology evaluation in collaboration with process development groups to improve Pilot Lab operation capacity, efficiency and process productivity. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the successful filings of Gilead’s biologics entities.

Key Responsibilities:

• Maintain a state-of-the-art purification lab that enables rapid new biologics entities manufacturability assessment, purification process development and scaleup.

• Contribute to material generation planning. Execute pilot scale purification operations. Support process scaleup and implementation in the Pilot Lab.

• Collect and analyze data from Pilot Lab runs in compliance with data integrity policy. Author and review batch records, protocols and reports.

• Transfer process to the Pilot Lab timely and with high success rate. Provide technical support for Pilot run atypical event investigations.

• Author and maintain Pilot Lab work instructions, standard operating procedures and training plans. Provide training to Pilot Lab operators.

• Mentor junior team members on Pilot Lab operation, batch record authoring, operation planning and execution as well as process transfer.

• Contribute to biologics manufacturing platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.

• Participate in cross functional initiatives as needed.

• Adhere to department budget and all training, compliance and safety requirements.

Qualifications/Skills/Experience:

• M.S. in Chemical Engineering, Bio-engineering, Biochemical Engineering, Biochemistry or related field with 4+ years (or B.S. with 6+ years) of industrial experience in biologics purification development and/or scaleup operations.

• Hands-on experience on pilot scale purification operation planning and execution. Experience in tech transfer process scale-up

• Working knowledge in single-use manufacturing technology.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Experience in data analysis (e.g. JMP, Spotfire), creating and maintaining batch records, authoring operation procedures and reports.

• Working knowledge of lab automation, data management, data science, knowledge management and data protection is a plus.

• Passion for inclusion: knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way he/she works.