- Vital to the success of Commercial Biologics QC, this role provides support of daily operations. Responsibilities include supporting outsourced testing coordination, sample management and shipping, reference standard inventories, and data entry from CTLs/CMOs into Gilead's LIMS. The role is accountable for refining QC procedures across Gilead's biologics manufacturing network, ensuring global cGMP compliance.
- Vital to the success of Commercial Biologics QC, this role supports daily operations. Responsibilities include managing the release testing supporting Gilead's commercial biologics drug substances and drug products. The role will contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System.
- Experience in biologics Quality Control with knowledge of industry best practices and trends.
- Understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
- Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
- Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
- Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
- Demonstrated the ability to influence process and outcomes across functions.
- Knowledge and experience in Biologics quality control.
- 4+ years of experience with a BA / BS degree in Chemistry or Biology; OR 2+ years of experience with MS degree in Chemistry or Biology
- Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
- Strong organizational and planning skills.
- Shows excellent verbal and written communication skills and collaborative interpersonal skills.
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Quality Control - Foster City, United States - Gilead Sciences, Inc.
Description
Description
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, California.
GMP Operations & Logistics:
Commercial Analytical Operations:
Responsibilities:
The Senior Research Associate II is vital for the success of Commercial Biologics QC, supporting daily operations. The Senior Research Associate II supports cross-functional teams, embraces continuous improvement, and ensures timely project completion and regulatory compliance.
The role will contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System.
Requirements:
You have:
Qualifications:
Gilead Core Values
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
The salary range for this position is: $99, $129, 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:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 for assistance.
