Sr. Research Scientist II, BAO
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. 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 phase-appropriate analytical method development, validation, trending, and transfer to QC laboratories for biologics drug substance and drug product testing.
- Lead the establishment of appropriately robust and reliable GxP analytical methods for QC testing to support biologics manufacturing activities at both internal and external manufacturing organizations.
- Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
- Apply analytical lifecycle management principle for establishment and continuous improvement of biologics analytical control strategy.
- Maintain strong knowledge of GMPs and manage external CTLs and CMOs.
- Lead biologics testing support for process and cell line development, provide strategic leadership to analytical testing services to ensure adequate resources and technologies are in place to support high throughput processing, and accurate and fast delivery of results.
- 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.
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and 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.
- 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.
- Lead, motivate, and develop the people in their group. Develop talent to deepen strength and increase capabilities, aligning with individual career goals. Foster good teamwork and communication amongst staff.
- Routinely make decisions affecting direction of project to ensure project timelines are met.
- Direct research associates or members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize biologics.
- Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
- Responsible for conducting scientific research for the development of biologics drug candidates or the research support of marketed drugs.
- May make contributions to scientific literature and conferences or regulatory filings.
Essential Education, Experience & Skills:
- Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with 5+ years of industry experience.
- MS degree with 10+ OR BS degree with 12+ years of industry experience.
- Must have practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and risk management.
- Applies the principles and techniques of Analytical Chemistry to biologics development. Strong scientific background in protein chemistry and biologics analytical methods.
- Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
- 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.
- Experience in IND/IMPD and market registrations of biologics in US and EU.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Strong analytical skills and ability to distill key information from various data sources
- Supervisory experience is required.
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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.
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.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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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