Sr Associate Scientist, Biologics Quality Control (Analytical Lifecycle Management)

Sr Associate Scientist, Biologics Quality Control (Analytical Lifecycle Management)

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.

Gilead’s 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 company’s five core values. That’s 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

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

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.

Analytical Lifecycle Management :

This role is vital for the success of Commercial Biologics QC, providing 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 analytical lifecycle management of commercial biologics drug substances and drug products.

Responsibilities :

The Senior Associate Scientist, Analytical Operations is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations.

The Senior Associate Scientist will collaborate with cross-functional teams, supporting the QC team lead on PDM (Pharmaceutical Development & Manufacturing) commercial project teams.

Focus Areas : You Will :

You Will :

• Contribute to the development and implementation of end-to-end Quality Control strategy for Gilead's portfolio of biologics products.
• Contribute to staff development, budgeting and cost control, and strategic planning of the Biologics Quality Control department.
• Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting and remediation of atypical results.

Requirements : You have :

You have :

• Experience with Biologics Quality Control sub-functions and extensive knowledge of industry best practices and trends.
• Experience with or demonstrated capacity to learn 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 support for Company-wide long-term solutions.
• Demonstrated an ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead's GMP policies.
• Demonstrated the ability to influence process and outcomes across functions.

Qualifications :

• BS degree in Chemistry, Biochemistry or related field with 6+ years' experience, or MS degree with 4+ years' experience.
• 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.

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 : $133,280.00 - $172,480.00. 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 :

https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing

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 [email protected] 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.

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