Senior Quality Control Associate, Biologics QC
2 weeks ago
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.
Job Summary:The Senior Quality Control Associate, 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.
Key Responsibilities:- Manage the release testing supporting Gilead's commercial biologics drug substances and drug products.
- Contribute to refining QC procedures across Gilead's biologics manufacturing network.
- Ensure 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.
- 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.
- The salary range for this position is: $133,000 - $172,000.
- 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.
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