Sr Scientist, Purification Process Development (Pivotal & Commercial)

Gilead Sciences • Foster City, CA

6d

About The Position

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.

Requirements

• Ph.D. with 2+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). OR M.S. with 6+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). OR BS with 8+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Nice To Haves

• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Experience in technology transfer of pivotal stage purification processes from 2-25 kL scale including understanding of process scalability, robustness, regulatory expectations, manufacturability and COGs
• Excellent communication, technical writing and presentation skills, and aptitude for creative problem solving
• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is desired
• Demonstrated ability to collaborate and influence cross-functionally
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire)
• Working knowledge of lab automation, data management, data science, knowledge management and data protection

Responsibilities

• Design experiments and demonstrate hands-on technical leadership of all aspects of purification process development including chromatography, TFF, virus filtration, harvest and virus clearance
• Provide scientific and technical leadership of one or more pivotal/commercial programs.
• Accountable for process characterization strategy, project plans, execution, risk management and delivery of functional objectives throughout the lifecycle including process optimization, process characterization, process performance qualification and technical reports for BLA submission
• Lead and/or support technology transfer, clinical resupply and investigation activities in partnership with Global Manufacturing Sciences and Technology (MSAT)
• Perform statistical analysis and appropriate modeling to assess process parameter criticality, identify acceptable ranges and contribute to the integrated control strategy
• Author and review GMP and non-GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs, etc.) ensuring data integrity and best documentation practices are followed
• Represent the Pivotal & Commercial Purification Development Department on cross-functional product development/CMC teams. Requires collaboration with Analytical Development, MSAT, Cell Culture, Formulation, Manufacturing, Quality, Regulatory, and Supply Chain, as needed.
• May manage direct reports and mentor junior team members on purification process development strategies, experimental design and execution and process transfer
• Help to establish and maintain a state-of-the-art purification lab
• Participate in cross-functional initiatives and business process improvements as needed
• Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities
• Evaluation and implementation of new technologies, workflows, or data approaches to improve development efficiencies and timelines

Benefits

• company-sponsored medical, dental, vision, and life insurance plans

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree