Gilead Sciences, Inc.
Sr Associate Scientist, Biologics Quality Control (Analytical Lifecycle Manageme
Gilead Sciences, Inc., Foster City, California, United States, 94420
Sr Associate Scientist, Biologics Quality Control (Analytical Lifecycle Management)Locations: United States - California - Foster City
Time Type: Full time
Posted on: Vor 3 Tagen
Job Requisition ID: R0042115
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.
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 Benefits
Equal Opportunity Employer:
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.
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Time Type: Full time
Posted on: Vor 3 Tagen
Job Requisition ID: R0042115
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.
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 Benefits
Equal Opportunity Employer:
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.
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