Gilead Sciences, Inc.
Senior Research Scientist I, Formulation and Process Development Pivotal & Comme
Gilead Sciences, Inc., San Mateo, California, United States, 94409
Senior Research Scientist I, Formulation and Process Development Pivotal & Commercial Biologics
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.Job Description
The
Senior Research Scientist I, Formulation and Process Development - Pivotal & Commercial Biologics
role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.Responsibilities:
Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations.Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.Work with functional leaders to develop a functional handbook to pursue business process and technical excellence.Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.May coach direct reports.Ability to travel up to 25% is required.Qualifications:
Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with 2+ years
OR
M.S. with 8+ years,
OR
B.S. with 10+ years of industrial experience in biologics CMC development.End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences.Experience of IND and/or BLA filings.Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.Working knowledge of lab automation, data science, and knowledge management.Hands-on in lab execution and has experience of training junior members.Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.People management experience is strongly desired.Experience working with contract development and manufacturing organization is highly preferred.Gilead Core Values
Integrity (Doing What's Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)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.For additional benefits information, visit: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.Job Description
The
Senior Research Scientist I, Formulation and Process Development - Pivotal & Commercial Biologics
role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.Responsibilities:
Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations.Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.Work with functional leaders to develop a functional handbook to pursue business process and technical excellence.Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.May coach direct reports.Ability to travel up to 25% is required.Qualifications:
Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with 2+ years
OR
M.S. with 8+ years,
OR
B.S. with 10+ years of industrial experience in biologics CMC development.End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences.Experience of IND and/or BLA filings.Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.Working knowledge of lab automation, data science, and knowledge management.Hands-on in lab execution and has experience of training junior members.Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.People management experience is strongly desired.Experience working with contract development and manufacturing organization is highly preferred.Gilead Core Values
Integrity (Doing What's Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)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.For additional benefits information, visit: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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