Senior Scientist I - GMP Manufacturing

at St. Jude Children's Research Hospital in Memphis, Tennessee, United States

Job Description

We have a Senior Scientist opportunity in the cGMP Manufacturing department at St. Jude Children’s Research Hospital.

The successful candidate will be self-motivated and highly organized, with experience working in a GMP facility, specifically with biological products.

This is an opportunity to assist with the process development and cGMP manufacturing of Influenza seed stocks, and with 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 with a strong degree of independence and minimal daily supervision. Will be trained to understand and follow 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).

The responsibilities for the Sr. Scientist will hold the following responsibilities:

+ 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 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.

+ 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).

Apply to be a part of the mission of St. Jude Children’s Research Hospital: to advance cures, and means of prevention, for pediatric catastrophic diseases through research and treatment. Consistent with the vision of our founder Danny Thomas, no child is denied treatment based on race, religion or a family’s ability to pay.

+ 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

Salary is highly competitive (comparable to industry) and employee benefits are outstanding. Relocation assistance is available. Working at St. Jude provides the opportunity to make a tangible difference to pediatric cancer patient care and survival and St. Jude has been consistently ranked in Fortune magazine’s “100 Best Places to Work” list and is exceptionally positively reviewed on GlassDoor.

COVID-19 vaccine:

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

No 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.

Posted Job Title: Senior Scientist I – GMP Manufacturing

WITS Req ID: 47829

Posted Department: Childrens GMP_LLC

Street: 262 Danny Thomas Place

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Job Posting: JC201670820

Posted On: Jan 11, 2022

Updated On: May 08, 2022