Gilead Sciences, Inc.
Research Scientist, Biologics Quality Control (Analytical Lifecycle Management)
Gilead Sciences, Inc., San Mateo, California, United States, 94409
Research 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.
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:
The Research Scientist, Analytical Lifecycle Management 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 leading the analytical lifecycle management of commercial biologics drug substances and drug products.
Requirements:
Experience over a broad set of Quality Control sub-functions with 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 the ability to motivate and engage individuals.Demonstrated the ability to influence process and outcomes across functions.
Qualifications:
PhD in Chemistry, Biochemistry or related field
OR
8+ years' related experience with a BS
OR
6+ years' experience with a MS in Chemistry, Biochemistry or related field.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)
Salary and Benefits:The salary range for this position is: $154,020.00 - $199,320.00. 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.
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.#J-18808-Ljbffr
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.
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:
The Research Scientist, Analytical Lifecycle Management 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 leading the analytical lifecycle management of commercial biologics drug substances and drug products.
Requirements:
Experience over a broad set of Quality Control sub-functions with 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 the ability to motivate and engage individuals.Demonstrated the ability to influence process and outcomes across functions.
Qualifications:
PhD in Chemistry, Biochemistry or related field
OR
8+ years' related experience with a BS
OR
6+ years' experience with a MS in Chemistry, Biochemistry or related field.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)
Salary and Benefits:The salary range for this position is: $154,020.00 - $199,320.00. 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.
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.#J-18808-Ljbffr