Manufacturing Associate - Viral Vectors

Thank you for your interest. Please note, the purpose of this posting is to recruit for on-going and future positions. 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 biological and viral vector 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 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 biological/viral vector 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 agencies.

Assist in development/adaptation of new manufacturing procedures.

Wear pager, or other communication devices, and respond to emergency calls.

Participate in the efforts to develop and adapt new procedures for manufacturing 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 techniques and industry practices.

Internal Contacts:

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.

External Contacts:

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.

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.

QualificationsBasic 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.

Experience in production and/or use of viral vectors is highly desirable.

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.

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.