- Vital for the success of Commercial Biologics QC, providing strategic leadership 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 is accountable for refining QC procedures across Gilead's biologics manufacturing network, ensuring global cGMP compliance.
- 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.
- The Research Scientist, Commercial Analytical Operations is vital for the success of Commercial Biologics QC, providing 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 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.
- 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.
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Quality Control - Foster City, United States - Gilead Sciences
Description
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. 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.
Research Scientist, Biologics Quality Control- We are seeking several individuals to support our GMP, Operations and Logistics team, Analytical Lifecycle Management team, and Commercial Analytical Operations team.
GMP Operations & Logistics:
Analytical Lifecycle Management:
Commercial Analytical Operations:
Requirements:
You have:
Qualifications:
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: $154, $199, 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*.
