Director, Analytical Operations
Director, Analytical Operations
United States - California - Oceanside
Gilead 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats 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 #CreatingPossible
- Lead, coach, develop, and inspire a team of seven analysts and scientists
- Coordinate and execute phase appropriate Critical Quality Attribute assessment studies
- Collaborate with research for the selection of clinical candidate and developability studies
- Collaborate with analytical and process development function for the execution of relevant studies necessary to support process development, process characterization and validation.
- Plan and execute analytical characterization studies to support phase appropriate comparability studies and reference standard qualification
- Write and review relevant sections of regulatory filings, and reports used as source documents
- Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.
- Guide the execution of relevant forced degradation and isolation and characterization of product and process related impurities
- Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trend into analytical development and control strategies.
- Explore, develop, acquire new technologies
- Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
- Partake in BAO leadership and work closely with the cross functional groups to achieve project and team strategic goals.
Essential Education, Experiences and Skills:
- Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with 15 years of industry experience.
- Must have a proven track record in mass spectrometry, proteomics, and protein biochemistry
- Broad and direct experience of managing a variety of analytical activities including characterization method development, reference standard, product characterization, comparability and CQA assessments.
- Must have experience in authoring analytical sections of early and late stage regulatory filings
- Must have a robust understanding of analytical operations and regulatory expectations
- Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.
- Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.
- Must think critically and creatively.
- Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
- Innovative, proactive, and resourceful; committed to excellence, quality and continuous improvement.
- Track record of publications in peer reviewed journals and oral communications at relevant conferences a plus
- Experience in several of the following fields is strongly desired: Analytical chemistry, biochemistry, biological Mass Spectrometry, high performance or ultra-performance liquid chromatography, electrophoretic separations, chemical and biophysical structural elucidation, and bioinformatics.
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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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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