Associate Scientist, 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. 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, CaliforniaRole Summary:
This role will be a lab-based role in quality control at Oceanside, CA responsible for instrument/system management across the department, as well as execution of GMP release and stability testing for drug substance and drug product samples in the potency and/or biochemistry laboratory.Role and Responsibilities:
Essential Duties and Job Functions:
- Manage an effective maintenance and calibration program for all laboratory instruments to ensure accuracy, reliability, and compliance with regulatory requirements.
- Perform quality control release and stability testing on drug substance and drug product for product quality assays including but not limited to SEC (Size exclusion chromatography), cIEF (capillary isoelectric focusing), CE-SDS (capillary electrophoresis sodium dodecyl sulfate), Potency ELISA, Residual ELISAs
- Contribute to method validation and/or method transfers
- Perform data review and data verification of internal and external contract laboratory data for early-stage and late-stage biologic programs
- Resource for Junior team members. May have people management responsibilities
Knowledge, Experience and Skills:
- Coordinate the calibration and maintenance of laboratory instruments with outside vendors, including scheduling and overseeing repairs and preventive maintenance.
- Analyze GMP release and stability samples
- Identify and troubleshoot instrument problems, implement corrective actions, and provide technical support to laboratory personnel.
- Work with laboratory personnel to evaluate new instruments and equipment, provide input on purchasing decisions, and oversee the installation and validation of new instruments.
- Knowledge of current Good Manufacturing Practices (cGMPs)
- Work with electronic laboratory systems such as LIMS, ELN, LES, and EMPOWER
- Support Quality Control functions and lab management.
- Write deviations, investigations, and CAPAs, particularly in relation to laboratory testing and OOS results
- The applicant should be an effective communicator of ideas, project goals, and results to team members across cross-functional roles/departments
- Candidates should be self-motivated and organized
- Ability to learn and apply knowledge of GMP practices in a Laboratory, including Part 11 and data integrity concepts
- Experience with High-Performance Liquid Chromatography (HPLC), ProteinSimple Maurice, Beckman PA800 plus CE, and/or SoftmaxPro
- Able to write standard operating procedures (SOPs), test methods, or protocols
- Perform job functions with a quality mindset
- Working knowledge and proficiency with Microsoft Office software
- Work independently and in a team setting
- Demonstrate good verbal communication skills and interpersonal skills
- Be able to work in a fast-paced and highly collaborative working environment.
- 5+ years of experience and a BS OR 3+ years of experience and MS degree in Microbiology, Chemistry, Biology, or other related science
- An understanding of current GMP practices
The salary range for this position is: $101,830.00 - $131,780.00. 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 email@example.com
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For Current Gilead Employees and Contractors:
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to apply for this job.