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
Responsible for manufacturing and testing of biological products under limited supervision. Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements in the manufacturing and testing of biopharmaceutical and genetic products manufactured in the Center for Biomedicine and Genetics (CBG). Perform manufacturing activities, process development tasks, quality control assays, release tests and assay development tasks as directed by supervisor. Perform general laboratory activities assigned by supervisor. Provide qualification and validation support for manufacturing processes and quality assurance procedures that are essential to the cGMP production of biomedical 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:
Basic education, experience and skills required for consideration:
- Manufacture and test biological products following established SOP under limited supervision.
- Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance.
- Participate in the efforts in achieving compliance with all Federal and State accrediting agency
- Assist in development/adaptation of new manufacturing procedures and analytical methodology.
- Perform general laboratory activities.
- Wear pager, or other communication devices, and respond to emergency calls.
- Perform manufacturing activities and release testing following established SOP. Participate in the efforts to develop and adapt new procedures for manufacturing and testing when necessary. Complete all documents in compliance to cGMP.
- Assist in creating, reviewing and revising Standard Operating Procedures as necessary.
- Assist in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and CBG 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.
- Maintains current knowledge of manufacturing/analytical techniques and industry practices.
- With supervisor and project team members within CBG. Interact with QA in the areas of assigned responsibility to engage activities do not require decision making (i.e. request for issuance of batch record or Biological material, etc.). Report equipment failure or alarms to facility officer, or QA team. Communicate with QC team for sample testing when directed by supervisor. Make scientific presentation occasionally to management team when requested.
- Communicate with external vendors to obtain technical information when directed by supervisor. Communicate with external collaborator to gain/clarify process or assay information when directed by supervisor.
- Budget/Financial Administration: None
- Wear a CBG issued pager, or other communication devices, and respond to all emergency calls for critical equipment failure at all time promptly.
- Attend and complete all mandatory trainings required by City of Hope and Center for Genetics and Biomedicine.
- Attend relevant scientific presentations/conferences as directed by supervisor. Prepare manuscript under supervision.
Preferred education experience and skills:
- BS degree in biological science or related field. Experience may substitute for minimum education requirements.
- 3-5 years related experience with B.S. degree or 0-4 year with M.S. degree
- Biotechnology, Pharmaceutical industry experience
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.