Sr. Research Scientist II, BAO
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. 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 scale
Inclusion 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 #CreatingPossibleJob Responsibilities:
Essential Education, Experience & Skills:
- Lead late-phase to commercial stage analytical control and comparability strategy in support of biologics drug substance and drug product process development.
- Familiar with key regulatory guidance in biologics CMC, and proficient in applying the principles to formulate risk-based and scientifically sound analytical strategies to fulfil regulatory requirement, the progression of the clinical programs, and to ensure the clinical and commercial supply.
- Apply analytical lifecycle management principle for establishment and continuous improvement of biologics analytical control strategy.
- Collaborate with biologics process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
- Perform critical data review and provide directions for troubleshooting and investigation.
- Maintain strong knowledge of GMPs and manage external CTLs and CMOs.
- Write/review development summary reports and author sections of regulatory submissions.
- Serve as a CMC lead and/or an analytical representative on biologics pharmaceutical development project teams.
- Routinely make decisions affecting direction of project to ensure project timelines are met.
- Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with 5+ years of industry experience, OR a MS degree with 10+ years OR a BS degree with 12+ years of relevant industry experience.
- Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
- Must have late phase to commercial stage CMC experience, in particular the practical knowledge of analytical life cycle and control strategy; capable of assessing regulatory and quality requirements using sound judgment and risk management.
- Experience in IND/IMPD and market registrations of biologics in US and EU is a must.
- Experience in analytical comparability strategy setting, including impact assessment, proposal of testing strategy, and appropriate acceptance criteria.
- Author and review relevant sections in regulatory filings.
- Strong scientific background in protein chemistry and biologics analytical methods.
- Strong CMC statistical skillset as applied to specification, stability, and comparability is desired.
- Strong analytical skills and ability to distill key information from various data sources.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Works under supervision of scientific directors to advance the development of biologics programs.
- Full working knowledge of principles and theories, applying such knowledge to the direction that supports company interests.
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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 firstname.lastname@example.org for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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