- Oversee CMC analytical activities within the Pharmaceutical Development and Manufacturing (PDM) organization to support clinical development from early clinical phases to commercial filing.
- Develop analytical control strategies for supporting small molecule drug clinical development and manufacturing for solid dosage forms and/or parenteral products.
- Consult with analytical development teams on experimental design and data interpretation, and employ data-driven approaches to devise and execute strategy.
- Lead analytical project team meetings and ensure that clear agendas are set, actions and decisions are documented, communicated, and committed to, enabling achievement of project goals.
- Proactively identify and find solutions to CMC critical path items and risks to successful development.
- Collaborate cross-functionally with analytical development, process chemistry, formulations development, method validation, release and stability groups, QA, and regulatory sciences.
- Effectively communicate with the cross-functional CMC project team members and key internal stakeholders, so that all parties are aware of current project status, issues, contingencies, and milestones.
- Author and review regulatory submissions, reports, specifications, and other documents required to support clinical manufacturing and development.
- Participate in departmental activities and improvements. Leadership in this area is encouraged.
- Maintain fluency in relevant regulatory and technical advancements.
- Minimum qualifications: PhD in Chemistry/Biochemistry with 2+ years of experience; or MS/BS degree with extensive industry experience (8+ years for MS and 10+ years for BS).
- Preferred qualifications: PhD in Chemistry/Biochemistry with 3+years of relevant analytical CMC experience; or MS/BS degree with extensive industry experience (12+ years for MS and 14+ years for BS).
- Demonstrated strong communication, organization and management (people and/or project) skills.
- Must have hands-on experience in design, execution, and data analysis of laboratory experiments to serve as a foundation for leading an analytical CMC project.
- Prior experience working with combination products, parenteral formulations, or regulatory filings are a plus. The salary range for this position is: $177, $230, 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*.
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Senior Research Scientist I, Analytical Development and Operations - Foster City, United States - Gilead Sciences, Inc.
Description
Description
Senior Research Scientist I, Analytical Development and Operations
Foster City, California
This role is in the Analytical Project Strategy (APS) team within Analytical Development and Operations (ADO), based at our headquarters in Foster City, CA. APS is responsible for CMC analytical activities related to the development of Gilead's small molecule drug substances and drug products.
Job Responsibilities:
Education and Experience:
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
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 for assistance.
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Senior Research Scientist I, Analytical Development and Operations professionals in Foster City
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vijay yelanji
Manager, Architect, Tech Lead and Developer