Scientist IV Quality Control

At St. Jude Childrens Research Hospital, we encourage you to dream big, and we give you everything you need to be the force behind our cures. We are looking for a Scientist IV-Quality Control to assist Children's GMP, LLC at St. Jude Childrens Research Hospital. The selected candidate will operate independently with minimal daily supervision to design methods for in-process, release and stability testing of biological products developed and produced in the Children's Good Manufacturing Practices (cGMP) facility at St. Jude Children's Research Hospital. The scientist will implements methods that meet Food and Drug Administration (FDA) regulatory requirements described in the International Conference on Harmonization (ICH) guidelines for biopharmaceutical products. Generates development reports that summarizes all work related to the development of a method, generates a Standard Operating Procedure (SOP), transfers the method, and trains the staff in the Quality Control (QC) laboratory to run the method. The scientist should have knowledge of and can perform analytical methods including gel electrophoresis, DNA/RNA extraction PCR applications, and tissue culture. The scientist must have the knowledge and ability to develop cell-based functional assays, ELISAs, product related residual testing.This scientist will interact closely with the Process Development group within the TPQ department on the development of release assays used to characterize the product during the production process or for product release. The scientist will work closely with the Quality Assurance Group and Quality Control Manager in the generation of documents, such as SOPS, qualification protocols and the qualification of the methods. Experience with cGMP and procedures, aseptic technique, tissue culture, and Droplet Digital PCR (ddPCR) preferred. The scientist must be capable of learning software, manipulating formulas, and assessing correctness. The selected candidate should have a strong understanding of teamwork and have excellent communication skills.

Responsibilities

The successful candidate will have the following responsibilities:

Develops analytical methods to assess purity, quantity, identity and characterization of products that meet cGMP requirements.
Works with the PD and Production groups to develop in-process assays to quantitate the product during manufacturing.
Generates reports of publication quality that accurately and professionally represent the development work. These documents are subject to FDA audits.
Generates SOPs that accurately describe the analytical method and demonstrates the ability to work in an FDA regulated environment.
Trains personnel in procedures and techniques of the laboratory.
Performs other related duties as assigned or directed to meet the goals and objectives of the department and the institution.
Performs critical review of reports and notebooks applying quality standards.

Minimum Education

Bachelors degree in a scientific field required.
Degree in biochemistry, chemistry, analytical chemistry or related field preferred.
Experience working in a cGMP environment preferred.

Minimum Experience

A minimum of six (6) years of relevant post-degree work experience required with a Bachelors degree in a scientific field.
A minimum of two (2) years of relevant post-degree work experience required with a Masters degree in a scientific field.
No previous work experience required with a Ph.D. in a scientific field.