Gilead Sciences, Inc.
Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biol
Gilead Sciences, Inc., San Mateo, California, United States, 94409
Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development
United 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 care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scaleInclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences, and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly striving to make a difference.Job Description
The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process 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 cell culture process technology development, platform process evolution, and cell culture-related regulatory documentation.Key Responsibilities:
Lead cell culture process development and implementation in internal and external GMP facilities, as well as technical support of GMP operations.Establish and maintain a state-of-the-art cell culture process development laboratory.Lead cell culture process technology development and platform process evolution projects for increased productivity, high-quality product, and speed to clinic.Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).Ensure high-quality documentation in electronic laboratory notebooks and reports.Author relevant sections of regulatory filings and responses to information requests.Support investigations and identify root causes for critical deviations.Travel as required to support technology transfers and provide oversight at external manufacturing facilities.Contribute to business process improvements related to early-stage process development.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.Qualifications/Skills/Experience:
Ph.D. with 2+ years
OR
M.S. with 8+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering)
OR
B.S. with 10+ 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 cell culture media development, and/or model development for upstream process development and optimization is preferred.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.Experience with viral vaccines 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.The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.
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United 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 care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scaleInclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences, and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly striving to make a difference.Job Description
The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process 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 cell culture process technology development, platform process evolution, and cell culture-related regulatory documentation.Key Responsibilities:
Lead cell culture process development and implementation in internal and external GMP facilities, as well as technical support of GMP operations.Establish and maintain a state-of-the-art cell culture process development laboratory.Lead cell culture process technology development and platform process evolution projects for increased productivity, high-quality product, and speed to clinic.Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).Ensure high-quality documentation in electronic laboratory notebooks and reports.Author relevant sections of regulatory filings and responses to information requests.Support investigations and identify root causes for critical deviations.Travel as required to support technology transfers and provide oversight at external manufacturing facilities.Contribute to business process improvements related to early-stage process development.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.Qualifications/Skills/Experience:
Ph.D. with 2+ years
OR
M.S. with 8+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering)
OR
B.S. with 10+ 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 cell culture media development, and/or model development for upstream process development and optimization is preferred.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.Experience with viral vaccines 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.The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.
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