Cell Manufacturing Associate II - CAR T Cell Manufacturing

About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary
Responsible for manufacturing and testing of biological products including, but not limited to, genetic T cell modification to express chimeric antigen receptors for cancer treatment 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) or Cellular Therapies Production Center (CTPC). Perform manufacturing activities, process development tasks, 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/CTPC 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:

• Minimum education:BS degree in biological science or related field.
  
• Experience may substitute for minimum education requirements.
  
• Minimum experience:3-5 years related experience with B.S. degree, or 0-4 year with M.S. degree.
  
• Required courses/training:Basic biology and chemistry.
  

Preferred education experience and skills:

• Preferred education:B.S. or M.S. in biological science, or related field.
  
• Preferred Courses/Training:Basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry), Virology, Immunology, Cancer biology.
  
• Preferred Experience:Biotechnology, Pharmaceutical industry experience.
  
• Have previous experience with cell therapy products; Excellent aseptic techniques;
  
• Strict adherence to SOPs and cGMP regualtions, the ability to accurately complete documentation associated with clinical manufacturing; Demonstrate trouble shooting and problem solving skills; Foster and promote a positive image and professional appearance; Organized and efficient; Excellent writing and computer skills;
  
• Able to correctly use technical terms and abbreviations; Comfortable with a fast-paced environment; Able to adjust workload based upon changing priorities.
  
• 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;
  
• Software:Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous device control software.
  
• Machines/Equipment:Dispensing pumps, heat sealers, welder, rotator, CliniMACS and/or and/or Prodigy and/or any cell separation equipment, magnetic separators, cell counting equipment, cell washers, flow cytometer, centrifuges, microscopes, biosafety cabinet and incubator.
  

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.