Associate Scientist, QC PDM
Associate Scientist, QC PDM
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
Associate Scientist, QC PDM
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.
- Support Quality Control functions for in-process, release, and stability sample processing for testing/retain/reserve storage and shipping support
- QC Program Owner for Reference Standards and execute the role of Reference Standard Administrator for all primary and working reference standards
- Responsible for sample plan creation/modification for internally and externally manufactured product and Quality System Database (GPLM) management for Contract Lab establishment and maintenance
- Responsible for ongoing management and support Laboratory information system templating and program maintenance
- Support Laboratory Operational Management for instruments and equipment through Change Management ownership, protocol and report generation and approval
- Conducts data review for release, stability and in-process testing
- Support the Quality Systems for creation/ ownership of change management, CAPA, trending, and other required metrics reporting
- Writing investigations related to CAPA systems, particularly in relation to Microbiology (Environmental/Clean Utility/In-Process Bioburden Monitoring excursions).
- Ability to review data in LIMS, test records, and laboratory notebooks
- Conducts routine analyses based on written procedures
- Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
- Possess and implements strong project management skills
- Performs maintenance and calibration of analytical instrumentation.
- Applies knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) daily.
- Participates in group meetings. May present data or prepare information for others to present.
- Conduct non-routine analysis of raw materials, intermediates, and finished product samples, as required.
- Troubleshoot instrumentation and test methods, as required.
- Assists in the training of QC staff, as needed.
- Working knowledge and proficiency with Microsoft Office software.
- Writes and executes protocols and reports.
- Evaluates equipment for purchase and performs installations and qualifications of the new instruments, as required.
- Troubleshoot instrumentation/test methods.
- Lead/coordinate QC and cross-functional projects with limited direction.
- Independently plans and executes assigned experiments that support routine development activities and project goals
- Writes and revises methods, specifications, and SOP's as needed.
Knowledge, experience, and skills:
- 10+ years of experience with AA degree
- 8+ years of experience with BS degree in a relevant scientific discipline.
- 6+ years of experience with MS degree in a relevant scientific discipline.
- Degree in Microbiology, Chemistry, Biology, or equivalent scientific discipline or equivalent work experience
- Intermediate skills with Microsoft Office software
- Basic to intermediate computer skills
- Basic knowledge of aseptic handling procedures
- Basic knowledge of safe handling of laboratory chemicals and reagents
- Hands on laboratory skills related to Microbiology and Chemistry testing
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 firstname.lastname@example.org for assistance.
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:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/Associate-Scientist--QC-PDM_R0016054
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