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Sr. Quality Control Associate - CAR-T Cell Therapy

City of Hope
Duarte, California
Closing date
Sep 28, 2022

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Life Sciences, Cell Biology, Other, Manufacturing/QA/QC
Position Type
Full Time
Organization Type
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Job Details

About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope's translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope's specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation's "Best Hospitals" in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

City of Hope's commitment to Diversity, Equity and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.

Position Summary

Supervise 0-2 direct reports and provide leadership in matrix project team as assigned. Responsible for completing assigned product testing tasks by performing the tasks personally, by directing junior associates, or by coordinating the efforts with project team members. Required to work under minimal or no supervision. Provide written and oral report to management on a regular basis. Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements in the testing of biopharmaceutical and genetic products manufactured at City of Hope cGMP facilities. Perform quality control assays, release tests and assay development tasks as directed by supervisor. Provide supervision and training to junior team members as directed by supervisor. Perform general laboratory activities occasionally as assigned by supervisor. Provide qualification and validation support for manufacturing processes and quality assurance procedures that are essential to the cGMP production of biomedical, small and large molecule products. Perform all cGMP related activities strictly according to SOP with accurate documentation. Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance. Required to wear pager, or other communication devices, and respond to emergency calls.

Key Responsibilities include:
  • Participate and supervise the testing of biological products, small and large molecule therapeutics.
  • Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance.
  • Create, review and revise SOP.
  • Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
  • Development/adapt of new analytical methodology independently.
  • Perform general laboratory activities as necessary.
  • Provide supervision to direct report(s), if any. Utilize proper managerial skills to accomplish assigned tasks.
  • Perform, or supervise, release testing following established SOP. Develop and adapt new procedures for product testing when necessary. Complete all documents in compliance to cGMP.
  • Create, review and revise Standard Operating Procedures.
  • Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope, OQS procedure requirements.
  • Participate in general laboratory activities as assigned by supervisor.
  • Complete and maintain all training required to perform assigned tasks.
  • Cooperate with other performance improvement and compliance activities within the department and in the institution.
  • Maintain current knowledge of analytical techniques and industry practices. Identify and adapt new analytical methodologies to enhance current capabilities.
  • Wear a COH issued pager, or other communication devices, and respond to all emergency calls promptly at all time for critical equipment failure.
  • Internal Contacts:
    • With supervisor and project team members within COH. Report equipment failure or alarms to facility officer, or QA team. Make scientific presentation and progress report to management team on a regular basis.
  • External Contacts:
    • Communicate with external vendors to obtain technical information as needed. Communicate with external collaborator to discuss assay conditions, or troubleshoot when directed by supervisor.
  • Attend and complete all mandatory trainings required by City of Hope, Office of Quality Systems
  • Attend relevant scientific presentations/conferences as directed by supervisor. Prepare manuscript under minimal supervision.

Basic education, experience and skills required for consideration:
  • BS degree in biological science or biochemistry related field . Experience may substitute for minimum education requirements.
  • 9+ years of relevant working experience with B.S. or M.S. degree

Preferred education experience and skills:
  • PhD in biological science or biochemistry related field.
  • Biotechnology, Pharmaceutical industry experience.

Additional Information:
  • May require a flexible work schedule; Subject to changing priorities and work assignments.
  • As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.



City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research.  City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

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