Senior Associate Scientist, Purification Process Development

仕事内容

Senior Associate Scientist, Purification Process Development - Pre-Pivotal Biologics – 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, Purification Process Development (Pre-Pivotal) will lead 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 lead 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. 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.
• Transfer process 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 purification platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.
• Contribute to workflow improvements for screening lead molecules screening with optimal developability.
• 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, bioengeering, biochemical engineering, biochemistry or related field with 5+ years or B.S. with 7+ years industrial experience in biologics purification development.
• Hands-on laboratory operations experience bench and pilot scale chromatography, TFF, VF and depth filtration.
• Experience in pre-pivotal stage purification process development, scaleup and implementation in GMP and non GMP manufacturing facilities.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• 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.
• Knowledge in single-use manufacturing technology and cGMP guideline is a plus.
• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.