Associate Scientist, QC (ELISA/Cell-Based Binding Assay)
Associate Scientist, QC (ELISA/Cell-Based Binding Assay)
United States - New Jersey - Morris Plains
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
Essential Duties and Job Functions:
- Responsible for cell-based potency and receptor binding assays on drug product and drug substance. Ensures timely delivery of test results to meet deadlines for delivery of accurate, verified release, and stability data.
- Accountable for maintenance of and documenting the performance of cell cultures for performance of cell-based potency assays.
- Performs timely and accurate review of laboratory results, proactively identifies and reports trends or suspect results, and thoroughly investigates and documents laboratory events and investigations.
- Effectively participates in the validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews, and approves analytical methods, validation protocols, and technical reports.
- Schedules and/or performs preventative maintenance and/or calibration activities, coordinates with external vendors for sample testing, instrument calibration and maintenance, and instrument installation, and ensures a state of inspection readiness.
- Provides subject matter expertise regarding the current format and analysis of bioassay data, prepares and presents technical data to management, and trains and mentors laboratory staff.
- Records data in a GMP compliant manner, performs peer and/or QC management review of routine and complex test results, authors simple reports and data summaries, validation protocols and reports, maintains and improves Quality Control GMP compliance and documentation and ensures integrity of QC data for support of regulatory submissions.
- Performs investigations to determine root cause, identifies CAPA activities, trains staff in investigation, root cause and CAPA processes, assists management in oversight of the investigations and CAPA systems, performs Change Control activities
- Actively seeks ways to improve compliance and efficiency in QC and other related areas, gathers and reports metrics to management and leads QC continuous improvement initiatives.
- Represents QC on cross-functional project teams, may lead cross-functional project teams
- Maintains required training and training records, trains staff as assigned, develops training materials as needed.
Essential Skills, Education & Experience:
- Bachelor's degree in Chemistry or related discipline with 5+ years OR a Master's degree with 3+ years of experience in a Biopharmaceutical and/or Biotechnology environment.
- Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
- Experience with statistical analysis and ability to prepare analytical reports, which include evaluation of trends.
- Experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines.
- Extensive knowledge and proficiency with cell biology, biochemical, and molecular biology methods and techniques.
- Proficiency with laboratory software applications.
- Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
- Must be able to work in a team environment and perform job responsibilities under minimal supervision.
- Must have familiarity with FDA and ICH guidelines and be able to follow SOPs and cGMP guidelines.
- Must be proficient with MS Office applications.
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 email@example.com 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.
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