Center for Biomedicine and Genetics Associate II
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.
- 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.
- Work 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.
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 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
- Preferred Courses/Training: Basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry), Virology, Immunology, Cancer biology
- Biotechnology, Pharmaceutical industry experience.
- Good written and oral communication skills.
- Team player, self-motivated.
- Ability to analyze data and compose reports; Ability to develop and update policies and procedures; Ability to set and model professional work standards;
- Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous.
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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