Gilead Sciences, Inc.
Senior QC Scientist, Biologics Quality Control (GMP Operations & Logistics)
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior QC Scientist, Biologics Quality Control (GMP Operations & Logistics)
Job Description
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 fulfill their aspirations. Join Gilead and help create possible, together.
GMP Operations & Logistics:This role is vital for the success of Commercial Biologics QC, providing support for daily QC operations. Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead’s LIMS. The role will contribute to QC procedures across Gilead’s biologics manufacturing network, ensuring global cGMP compliance.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: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: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:
Gilead BenefitsAs 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.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.
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Job Description
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 fulfill their aspirations. Join Gilead and help create possible, together.
GMP Operations & Logistics:This role is vital for the success of Commercial Biologics QC, providing support for daily QC operations. Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead’s LIMS. The role will contribute to QC procedures across Gilead’s biologics manufacturing network, ensuring global cGMP compliance.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: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: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:
Gilead BenefitsAs 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.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.
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