Sr Quality Control Manager

Location
Duarte, California
Salary
Competitive
Posted
June 06 2021
Ref
10011467
Position Type
Full Time
Organization Type
Healthcare/Hospital
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:

The Sr. Manager will effectively manage the QC team by providing technical training and supervision, prioritizing assigned tasks, and reviewing and approving testing results; meeting the expected deadlines is a critical part of the position. Responsible for assuring compliance with all Federal and State laws & regulations and other accrediting agency requirements in quality control assay development, data collection and evaluation, preparation of laboratory protocols and reports for the release of Biologics (vectors and cellular products) manufactured within the GMP facilities at COH. Responsible for development of analytical methods required for product release or in-process sample testing, generating of SOPs, reviewing and approval of all release test results. Provides consultation to Principal Investigators within COH to establish a scientifically sound product releasing strategy, including the selection of analytical methods and setting of release specifications. Oversees quality control staff and maintains the quality control laboratory. Provides validation support for all laboratory equipment, and approves all outcomes, which are essential to the release of biologics, antibodies and cellular products. This includes the documentation of processes and maintenance of records. The Sr. Manager will work with QA and manufacturing staff to increase the overall productivity of the GMP facilities.

Key Responsibilities include:
  • Recruits, manages, and provides technical training to QC staff to perform tasks in cGMP facility.
  • Oversees quality control activities for products to ensure compliance with Good Manufacturing Practices (GMP) for the Biologics and Cellular GMP Facilities.
  • Establishing and performing all necessary in-house assays to release products, including viral vectors, plasmid DNA, antibodies, recombinant proteins, and cellular products.
  • Reviews and revises standard operating procedures as necessary. Assists in the preparation of new standard operating procedures as directed by supervisor(s)
  • Reviewing and approving assays performed by 3rd parties. Interacting with internal and external testing service providers to ensure the quality of the service received.
  • Develop necessary assays for product release and process monitoring.
  • Continue to update existing assays to enhance their quality and the assay efficiency.
  • Explore new technologies to enhance the analytical capability of the center.
  • Actively participate with manufacturing project teams to provide analytical input and develop necessary assay to address specific project needs.
  • Reviews and signs off on QC batch records and assures that the proper procedures and processes have been used in the release testing of products and raw materials.
  • Shares responsibility with the QA Officer for preparedness for inspections by regulatory agencies so that there is a positive outcome and a minimum disruption in the daily operation and insures that agency inspectors are provided with all necessary information. Assists in the preparation of responses to recommendations of other regulatory requirements.
  • Reviews all completed QC release test reports and other QC related reports that are generated. Review and approve Certificate of Analyses (CoA).
  • Maintains knowledge of current advances in laboratory equipment and technologies in molecular and cellular biology.
  • May be required to attend pertinent conferences and job-related off-site training.
  • Cooperates with other performance improvement and compliance activities in the institution.
  • Maintain active training records.
  • Maintains knowledge of current regulatory/accreditation requirements, changes and issues, inspection citations, quality control training, management, and organizational development activities.


Basic education, experience and skills required for consideration:
  • A Master's Degree with coursework in biochemistry, molecular biology, or life science related fields with 10 (ten) years of experience.
  • Familiar with analytical methods employed in modern cell biology, molecular biology and virology laboratories, including Q-PCR, capillary electrophoresis, FACS, ELISA, infectious titer assay, etc.
  • Experience in cell-based assays and release of cell products.
  • Supervisory experience is required, preferably in an industrial setting.


Preferred education, experience and skills required for consideration:
  • Ph.D. in biochemistry, molecular biology, or life science related fields preferred
  • Five years of quality control/research experience in manufacturing of biologics
  • Experience in release testing biological products used in phase I/II clinical trial and demonstrated ability to develop analytical methods suitable for release testing is highly desirable.


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.

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  • Posting Date: Jun 4, 2021
  • Job Field: Research
  • Employee Status: Regular
  • Shift: Day Job

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