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Quality Control Manager - GMP Manufacturing

Company:
City of Hope
Location:
Duarte, CA
Posted:
April 16, 2024
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Description:

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

The QC team for Cellular and Gene Therapy Operations seeks a skilled Quality Control Manager to oversee in-process and release testing for GMP Manufacturing and analytical development of cellular immunotherapy products.

As a successful candidate, you will:

· Manage QC staff and oversee in-process and release testing for GMP Manufacturing of cellular immunotherapy products.

· Develop analytical methods, review SOPs, and ensure compliance with GMP standards.

· Maintain the quality control laboratory and provide validation support for laboratory equipment.

· Prepare and review QC batch records and release test reports.

· Assist in preparing for regulatory inspections and responding to regulatory requirements.

· Stay updated on advances in laboratory equipment and technologies in molecular and cellular biology.

· Cooperate with Manufacturing, QC, and QA teams to ensure cGMP compliance.

· Support performance improvement and compliance activities within the department and institution.

· Adhere to City of Hope policies, procedures, and safety guidelines.

Your qualifications should include:

· Bachelor's degree in biology or chemistry.

· Minimum five years of quality control/research experience in GMP manufacturing.

· 1-2 years of supervisory/managerial experience preferred.

· Master's or PhD degree in biology or chemistry preferred.

· Experience in biotechnology or pharmaceutical industry.

· Proficiency in cell viability, Flow Cytometry Assays, ELISA, RT-PCR, and cytotoxicity assays.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

Shift: Days

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