Biologics Quality Control Associate
1 week ago
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. Our mission is to create a healthier world for all people by advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
Job SummaryWe are seeking a highly skilled and experienced Senior QC Associate to join our Commercial Analytical Operations team. The successful candidate will provide support for strategic leadership and oversight of daily operations, managing the release testing of Gilead's commercial biologics drug substances and drug products.
Key Responsibilities- Manage the release testing of commercial biologics drug substances and drug products
- Refine QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System
- Develop and improve complex concepts, techniques, and standards based on quality principles and theories
- Exercise judgment and independently determine and take appropriate action where precedent may not exist
- Work with senior management to develop and ensure the implementation of Company-wide long-term solutions
- 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
- Ability to develop and improve complex concepts, techniques, and standards based on quality principles and theories
- Ability 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
- 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
- Ability to think critically and creatively and work independently to determine appropriate resources for resolution of problems
- Strong organizational and planning skills
- Excellent verbal and written communication skills and collaborative interpersonal skills
Gilead Sciences is committed to creating a diverse and inclusive work environment that values individual differences and recognizes each employee as an integral member of our company. We promote and support individual differences and diversity of thoughts and opinion.
We believe in the importance of teamwork, accountability, and excellence in all aspects of our business. Our employees are our greatest asset, and we strive to provide a work environment that is free of harassment and prohibited conduct.
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