at St. Jude Children's Research Hospital in Memphis, Tennessee, United States
The Children’s GMP_LLC has multiple vacancies for Sr. Scientist I GMP Manufacturing. We are looking for experienced professionals with ability to work in an independent fashion with minimal daily supervision on the manufacturing of biological products, including monoclonal antibodies, recombinant proteins, gene therapy vectors (Adeno-associated virus and Lentivirus), and live viral vaccines for Phase I and II human clinical trials at St. Jude Children’s Research Hospital.The Sr. Scientist I will have appropriate scientific expertise and understanding of the regulations governing the production of biopharmaceuticals as mandated by the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Manufacturing processes will meet the requirements for drug substance and drug products as mandated by the Food and Drug Administration.
+ Works with the Director of cGMP Manufacturing on the transfer and scale-up of processes into cGMP manufacturing for both Drug Substances (bulk) and Drug Products (vialed product).
+ Run tech transfer and scale-up runs in the cGMP suite(s).
+ Understand and assist in developing production batch records. Suggest revisions and updates to SOPs related to the operation of production equipment, facilities, cGMP utilities, and procedures to the manager of cGMP manufacturing.
+ Operate cGMP manufacturing equipment and control software for buffer preparation, manufacturing of the drug substance (bulk) and drug product.
+ Assists in training of appropriate cGMP staff on equipment required in the manufacturing process.
+ Ensures cGMP manufacturing suites are cleaned and released by QA prior to initiating cGMP manufacturing campaigns.
+ Collaborates with the Director of cGMP manufacturing to develop, write and revise Master Batch Production Records (MBPR).
+ Performs other related duties as assigned to meet the goals and objectives of the entire department and the institution
+ B.S. required with M.S. or Ph.D. in biological sciences, with a preference in biotechnology, chemical engineering or bioprocessing
+ With a B.S., 5 years of laboratory experience is required, preferably in cGMP Manufacturing.
+ With a M.S. or Ph.D., 1-2 years of experience in bioprocessing or cGMP manufacturing is preferred.
+ Upstream and Downstream cGMP experience in the biotechnology industry or other GMP facility preferred.
As of September 10, 2021, St. Jude Children’s Research Hospital has mandated the COVID-19 vaccine for all employees, excluding those with an approved medical or religious accommodation, as a condition of employment.
EEO Statement: St. Jude is an Equal Opportunity Employer
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Posted Job Title: Senior Scientist I GMP Manufacturing
WITS Req ID: 46458
Posted Department: Childrens GMP_LLC
Street: 262 Danny Thomas PlaceTo view full details and how to apply, please login or create a Job Seeker account