Gilead Sciences, Inc.
Sr Associate Scientist, Purification Process Development – Pivotal & Commercial
Gilead Sciences, Inc., Foster City, California, United States, 94420
Sr Associate Scientist, Purification Process Development – Pivotal & Commercial Biologics
United States - California - Foster City Process/Product Development & Operations Regular 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
Sr Associate Scientist, Purification Process Development (Pivotal and Commercial)
will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution. Key Responsibilities: Contribute to experimental design. Plan and execute assigned 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 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. Travel as required to support technology transfers and provide oversight at external manufacturing facilities. Provide technical support for manufacturing atypical event investigations. Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports. Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer. Help to establish and maintain a state-of-the-art purification lab. Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials. Participate in cross functional initiatives as needed. Adhere to department budget and all training, compliance and safety requirements. Qualifications/Skills/Experience: M.S. with 3+ years or BS with 5+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). Preferred Qualifications: Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required. Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Experience with AKTA chromatography systems and UNICORN software is preferred. Working knowledge of lab automation, data management, data science, knowledge management and data protection. Demonstrated ability to collaborate and influence cross-functionally. Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire). Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.
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United States - California - Foster City Process/Product Development & Operations Regular 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
Sr Associate Scientist, Purification Process Development (Pivotal and Commercial)
will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution. Key Responsibilities: Contribute to experimental design. Plan and execute assigned 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 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. Travel as required to support technology transfers and provide oversight at external manufacturing facilities. Provide technical support for manufacturing atypical event investigations. Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports. Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer. Help to establish and maintain a state-of-the-art purification lab. Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials. Participate in cross functional initiatives as needed. Adhere to department budget and all training, compliance and safety requirements. Qualifications/Skills/Experience: M.S. with 3+ years or BS with 5+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). Preferred Qualifications: Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required. Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Experience with AKTA chromatography systems and UNICORN software is preferred. Working knowledge of lab automation, data management, data science, knowledge management and data protection. Demonstrated ability to collaborate and influence cross-functionally. Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire). Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.
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