CBG Associate Senior
Department: CENTER FOR BIOMEDICINE & GENET
Requisition ID: 1606
Schedule Type: Full-Time
Location: Beckman Research Inst(Duarte)
Requisition ID: 1606
Title: CBG Associate Senior
Supervise 0-2 direct reports and provide leadership in matrix project team as assigned. Responsible for completing assigned manufacturing and product testing tasks by performing the tasks personally, by directing junior associates, or by coordinating the efforts with project team members. Required to work under minimal or no supervision. Provide written and oral report to management on a regular basis. 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 at 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. Provide supervision and training to junior team members as directed by supervisor. Perform general laboratory activities occasionally as 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.
* Participate and supervise the manufacturing and testing of biological products.
* Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance.
* Create, review and revise SOP.
* Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
* Development/adapt of new manufacturing procedures and analytical methodology independently.
* Perform general laboratory activities as necessary.
* Wear pager, or other communication devices, and respond to emergency calls.
* Provide supervision to direct report(s), if any. Utilize proper managerial skills to accomplish assigned tasks.
* Perform, or supervise, manufacturing activities and release testing following established SOP. Develop and adapt new procedures for manufacturing and product testing when necessary. Complete all documents are in compliance to cGMP.
* Create, review and revise Standard Operating Procedures.
* Assists 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. Identify and adapt new manufacturing and analytical methodologies to enhance current capabilities.
* Wear a CBG issued pager, or other communication devices, and respond to all emergency calls promptly at all time for critical equipment failure.
Minimum Education and Qualifications Required:
* BS degree in biological science or related field, required, MS preferred; plus 9 years of related experience.
* Experience may substitute for minimum education requirements
* 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 strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. Equal Opportunity / Affirmative Action Employer.