- Vital for the success of Commercial Biologics QC, this role provides support for strategic leadership and oversight of daily operations. Responsibilities include managing commercial specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of commercial biologics drug substances and drug products.
- Vital for the success of Commercial Biologics QC, this role provides support for strategic leadership and oversight of 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 with Biologics Quality Control sub-functions and extensive knowledge of industry best practices and trends.
- In-depth 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.
- Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
- Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
- Demonstrated the ability to influence process and outcomes across functions.
- 10+ Years' experiences with BS, OR 8 + Years with MS OR 2+ years of experience and PhD in Chemistry, Biochemistry or related field.
- Deep knowledge and experience in Biologics quality control. Stays ahead of shifting trends in industry.
- 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.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Quality Control - Foster City, United States - Gilead Sciences, Inc.
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we're creating a healthier world for all people.
For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.Job 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.
Senior Research Scientist I, Biologics Quality Control- We are seeking several individuals to join our Analytical Lifecycle Management team and Commercial Analytical Operations team.
Analytical Lifecycle Management:
Commercial Analytical Operations:
Requirements:
You have:
Qualifications:
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: $177, $230, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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:
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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.