Research Scientist, Purification Development
1 month ago
Research Scientist, Purification Development - Pre-Pivotal Biologics 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. Job Description: The Research Scientist, Purification Process Development (Pre-Pivotal) will lead purification unit operation development including experimental design, planning, execution and implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also lead projects for purification process technology development and platform process evolution. 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. Lead purification unit operation process development. Design and conduct laboratory scale experiments independently. Present experimental findings and recommendations to department senior staff. Ensure data generation/data integrity compliance. Author 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. Support manufacturing atypical event investigations. Support non-GMP pilot lab operations. Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports). Author IND/INDa CMC sections. Support Health Authority interactions and product-related inspections. Mentor junior team members on purification process development, experimental design and execution as well as process transfer. Keep abreast of technology/innovation trends and best industry practices. Plan and execute purification platform development, new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline. Contribute to workflow improvements for screening lead molecules with optimal developability. Participate in cross functional initiatives. Adhere to department budget and all training, compliance and safety requirements. Qualifications/Skills/Experience: Ph.D. in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field and 0+ years experience OR MS with 6+ years or B.S. with 8+ years industrial experience in biologics purification development. Hands-on laboratory operations experience in 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. Experience in authoring IND/INDa CMC sections. 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/data management, single-use 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. #J-18808-Ljbffr
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Research Scientist, Purification Development
2 months ago
Foster City, California, United States Gilead Sciences, Inc. Full timeResearch Scientist, Purification Development - Pre-Pivotal BiologicsUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the...
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Research Scientist, Purification Development
2 months ago
Foster City, California, United States Gilead Sciences, Inc. Full timeFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site $) to apply for this job.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...
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Foster City, California, United States Gilead Sciences, Inc. Full timeFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site $) to apply for this job.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...
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