Sr. Associate Scientist, Process Development
United States - California - La Verne
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.
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Job DescriptionSr. Associate Scientist, Process DevelopmentLa Verne, California
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead has an opportunity for a Sr. Associate Scientist to provide commercial and clinical fill operational support at our La Verne site. We are seeking an individual with the technical knowledge of process and analytics in the development, implementation, and management of Continuous Process Verification (CPV). The Sr. Associate Scientist should have a solid understanding of pharmaceutical product manufacturing. Essential Duties and Job Functions:
- Leads technical support activities related to maintaining commercial product supplies through management of internal and external resources.
- Contributes to and leads complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
- Contributes to and leads technical investigations of process deviations, and assessment of their impact on product quality. Defines requirements for, and reviews master batch records.
- Contributes to user requirement specification and provides expert process technical support to utilize and validate new and improved technologies.
- Liaises with manufacturing groups to deliver new and improved drug products and processes.
- Can lead one or more specific components of departmental strategic initiatives.
- Revises, improves, or develops new methods to support commercial products; writes protocols and reports.
- Assists with bench experiments to support collaborations with external researchers.
- Identifies and introduces new technology and/or methods to the organization, and trains junior staff on their implementation.
- Analyzes and identifies risks with processes, technologies, and methods, creates a working plan to prevent potential issues.
- Designs experiments and ensures they accomplish goals.
- Identifies opportunities to improve processes within the business and provides technical expertise and support to process improvement efforts.
- May supervise personnel, including organizing and prioritizing daily tasks, and performing training.
Education and Experience Requirements:
- Experience with statistical data analysis tools is preferred.
- Strong project management and organizational skills.
- Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
- Excellent troubleshooting skills and ability to solve complex technical issues.
- Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
- Strong interpersonal and communication skills, verbal and written.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- High degree of technical competence and effective communication skills, both oral and written.
- Able to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- BS in Biology, Chemistry or Physics and 6+ years of experience; or MS degree and 4+ years of experience.
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer.
The salary range for this position is: $117,725.00 - $152,350.00. 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. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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
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