Sr. Scientist I GMP Manufacturing
Company: St. Jude Children's Research Hospital
Posted on: September 14, 2020
With resources to help you succeed and develop your career, we
also offer generous relocation assistance.The GMP Manufacturing
department at St. Jude Children's Reserach Hospital is looking for
a Sr. Scientist I to mainly assist with the process development and
cGMP manufacturing of Influenza seed stocks. The successful
candidate will have excellent aseptic techniques, the 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. Has 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
The responsibilities for the Sr. Scientist will hold the following
- Works on the process development and cGMP Manufacturing of
Influenza seed stocks in BSL2/BSL3 labs and cGMP manufacturing for
both Drug Substances (bulk) and Drug Products (vialed
- 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
- 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
- B.S. required with M.S. or Ph.D. in biological sciences, with a
preference in biotechnology, chemical engineering or
- 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
St. Jude is an Equal Opportunity EmployerNo Search Firms:St. Jude
Children's Research Hospital does not accept unsolicited assistance
from search firms for employment opportunities. Please do not call
or email. All resumes submitted by search firms to any employee or
other representative at St. Jude via email, the internet or in any
form and/or method without a valid written search agreement in
place and approved by HR will result in no fee being paid in the
event the candidate is hired by St. Jude.
Keywords: St. Jude Children's Research Hospital, Raleigh , Sr. Scientist I GMP Manufacturing, Other , Raleigh, North Carolina
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