CBG Associate II - Cell Therapy
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:
- 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 requirements.
- 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.
Basic education, experience and skills required for consideration:
- BS degree in biological science or related field, plus 3-5 years related experience or a MS in biological science or related field degree with 0-4 years of related experience. Experience may substitute for minimum education requirements.
- Required Courses/Training: Basic biology and chemistry.
- Preferred Courses/Training: Basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry), Virology, Immunology, or Cancer biology.
- Good written and oral communication skills, team player, self-motivated excellent personal hygiene. Practice good judgment in all professional activities. Ability to analyze data and compose reports. Ability to develop and update policies and procedures. Ability to set and model professional work standards.
- For more information on Dr. Joseph Gold’s research at City of Hope please visit, here.
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.