Senior Research Associate I, Analytical Outsourcing & Stability (AOS)

Senior Research Associate I, Analytical Outsourcing & Stability (AOS)
United States - California - Foster City

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

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Senior Research Associate I, Analytical Outsourcing & Stability (AOS)

Specific Responsibilities

• Independently perform GMP analysis following written procedures using analytical techniques such as appearance, water content, dissolution, disintegration, liquid chromatography, DSC, particle size, XRPD, and UV-Vis spectroscopy
• Review testing data and results to ensure compliance to appropriate test methods, specifications, and protocols
• Apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis
• Troubleshoot instrumentation and test methods
• Perform stability data trending
• Support laboratory investigations and deviations
• Write and execute stability sampling plans, study protocols, and reports as needed
• Participate in group meetings. May present data or prepare information for others to present.
• Assists in the training of stability staff as needed
• Use Microsoft Office software applications to write, revise, and execute protocols, methods, specifications, Standard Operating Procedures (SOPs), and reports

Knowledge & Skills

• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, Dissolution, KF titration, GC, DSC/TGA, particle size, XRPD, disintegration, etc.
• Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments
• Strong working knowledge of cGMP and quality control (QC)
• Deep understanding of experimentation and data analysis using Empower software (Version III)
• Working knowledge of software such as Microsoft Office LIMS, LabX, electronic notebooks, Trackwise, etc.
• Demonstrates effective time management skills and ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude
• Demonstrates the ability to clearly and concisely present/explain testing and analysis results to multiple internal audiences
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
• Excellent verbal and written communication skills
• Experience in stability and testing of biologics, although not required, a plus
• Serve as a project coordinator for compendial review program, provide support to SME(s) to track pharmacopeia publication schedules, and initiate review process for identification, assessment, and implementation of pharmacopeia changes.
• Create, manage, and complete quality records in GTrack (i.e. CAPAs, change managements, etc.) for review, evaluate, and implement compendial changes which may result in changes to procedures, processes, or systems used by Gilead Sciences.
• Support SMEs to assess compendial changes to determine the impact to internal procedures, processes, or systems.
• Support SMEs/document owners to create/revise document(s)/process to align with pharmacopeia changes and to increase process efficiency and compliance.

Required Education & Experience

• A Bachelor's Degree in Chemistry, Biology or equivalent with a minimum of two (2) years of relevant experience in an analytical GMP regulated environment OR a Master's Degree in Chemistry, Biology or equivalent.

Preferred Experience

• Prior experience working in a QC/GMP laboratory.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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 careers@gilead.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:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Senior-Research-Associate-I--Analytical-Outsourcing---Stability--AOS-_R0022348





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