Center for Biomedicine and Genetics Associate II
Responsible for manufacturing and testing of biological products under limited supervision in a state-of-the-art manufacturing facility. 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. Will wear a pager, or other communication device to be responsive to emergency calls.
- 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 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.
- Maintain current knowledge of manufacturing/analytical techniques and industry practices.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- BS degree in cell biology, or related field. Masters degree, preferred. Experience may substitute for minimum education requirements.
- 3-5 years experience with biopharmaceutical and/or genetic manufacturing experience with B.S. degree, or 0-4 year with M.S.
- cGMP manufacturing experience, required.
- Foster and promote a positive image and professional appearance; Organized and efficient; Demonstrate proficiency in basic laboratory skills; Excellent writing and computer skills; Able to correctly use technical terms and abbreviations.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.
City of Hope is 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.
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