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Quality Control Specialist, Biologics Manufacturing
2 months ago
Gilead Sciences, Inc. is a leading biopharmaceutical company dedicated to creating innovative medicines to prevent and treat life-threatening diseases. We are seeking a highly skilled Senior Associate Scientist to join our Commercial Biologics Quality Control team.
Key Responsibilities- Manage the release testing process for Gilead's commercial biologics drug substances and drug products.
- Contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System.
- Collaborate with senior management to develop and implement Company-wide long-term solutions.
- 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.
- Experience in 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 solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness.
- Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
- Demonstrated ability to motivate and engage individuals.
- Demonstrated ability to influence process and outcomes across functions.
- 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.
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
