Gilead Sciences, Inc.
Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Developm
Gilead Sciences, Inc., Foster City, California, United States, 94420
Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development – Foster City, CA
United States - California - Foster City Process/Product Development & Operations Regular
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, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture 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 cell culture process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.
Key Responsibilities:
Plan and execute cell culture process development laboratory studies and support process implementation in internal and external GMP facilities.
Provide technical support for GMP operations.
Establish and maintain a state-of-the-art cell culture process development laboratory.
Lead studies for cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
Contribute to design of and conduct laboratory scale experiments; hands-on laboratory execution is expected, including weekends.
Maintain cell culture laboratory equipment and supplies.
Author and review experimental protocols and reports.
Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
Collect and analyze data from laboratory experiments.
Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
Adhere to department budget and all training, compliance and safety requirements.
Mentor junior team members on cell culture process development strategies and experimental design and execution.
Participate on cross-functional initiatives as needed.
Qualifications/Skills/Experience:
PhD with 0+ years
OR
M.S. with 4+ years
OR
B.S. with 6+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).
Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
Experience in pre-pivotal stage cell culture process development and implementation in GMP 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.
Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works
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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, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture 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 cell culture process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.
Key Responsibilities:
Plan and execute cell culture process development laboratory studies and support process implementation in internal and external GMP facilities.
Provide technical support for GMP operations.
Establish and maintain a state-of-the-art cell culture process development laboratory.
Lead studies for cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
Contribute to design of and conduct laboratory scale experiments; hands-on laboratory execution is expected, including weekends.
Maintain cell culture laboratory equipment and supplies.
Author and review experimental protocols and reports.
Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
Collect and analyze data from laboratory experiments.
Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
Adhere to department budget and all training, compliance and safety requirements.
Mentor junior team members on cell culture process development strategies and experimental design and execution.
Participate on cross-functional initiatives as needed.
Qualifications/Skills/Experience:
PhD with 0+ years
OR
M.S. with 4+ years
OR
B.S. with 6+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).
Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
Experience in pre-pivotal stage cell culture process development and implementation in GMP 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.
Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works
#J-18808-Ljbffr