Scientist-Quality Control

St. Jude Children's Research Hospital/Children's GMP, is seeking a Scientist Quality Control to join our team. This position offers an exciting opportunity for a skilled professional to play a pivotal role in ensuring the quality and efficacy of biological products. This position requires an individual who can operate autonomously while collaborating closely with the Quality Control Manager and Director to design and implement biological and analytical methods for in-process, release, and stability testing of biological products developed and produced at St. Jude Children's Research Hospital/Children's GMP, LLC.

The ideal candidate will be responsible for assay development and assay qualification as per Food and Drug Administration (FDA) and International Conference of Harmonization (ICH) guidelines for biopharmaceutical products. The position requires the technology transfer of assays from the laboratories of internal principal investigators and outside entities, as well as the development of an experimental plan to further develop the method so that it can be used for either release or characterization of the products manufactured by Children's GMP, LLC. The candidate will generate Standard Operating Procedures (SOPS), Assay Development Reports, Assay Qualification Protocols. As the subject matter expert on a developed method, the QC Scientist will be expected to tech transfers these methods to train the QC staff on the procedure.

Job Responsibilities:

• Develops innovative analytical methods to assess product safety, purity, quality, identity, and potency to ensure all products meet cGMP requirements.

• Performs troubleshooting or provides process improvements for assays that are in use, either directly or within a team framework, to ensure accurate and timely result reporting.

• Works with process development teams to develop in-process or final release assays for products developed and manufactured by TPQ/CGL.

• Works with Manager/Director of Quality Control to continuously improve the established assays to stay current with industry standards.

• Provide inputs regarding revisions to SOPs and/or process flows within area.

• Monitor and document compliance with quality and regulatory requirements and address deviations.

• Perform other duties as assigned to meet the goals and objectives of the department and institution.

• Maintains regular and predictable attendance.

SPECIAL SKILLS, KNOWLEDGE, AND ABILITIES:

• Strong background and understanding of biological sciences and related procedures.

• Hands-on experience with dPCR, ELISA, Cell and Tissue Culture, Flow Cytometry, and NGS.

• Proven ability to develop and execute analytical methods, with knowledge of current Good Manufacturing Practices (cGMP).

• Effective problem-solving skills, with a proactive and self-starting attitude, and strong team collaboration abilities.

• Strong written communication skills and experience with Microsoft Office, especially Excel.

• Experience with GxP systems or software use within a regulatory environment is preferred.

Minimum Education and/or Training:

• Bachelor's in biochemistry, chemistry or analytical chemistry or related field required.

• Master's OR PhD preferred.

Minimum Experience:

• Minimum Requirement: Bachelor's degree with 7+ years experience in relevant scientific area (e.g., GMP: chemistry, biology, chemical engineering, analytical chemistry, biotechnology; ECTL: cellular biology, molecular biology, immunology, biochemistry).

• Experience exception: 5+ years of experience in relevant area with Master's.

• Experience exception: 3+ years of experience in relevant area with PhD.

• Experience in cell-based biological assays, Next Generation Sequencing (NGS) and experience with Illumina platforms is preferred.

• Experience in tissue culture and aseptic technique is preferred.

• Ability to develop biological assays is preferred.

• Experience in a cGMP compliant environment is preferred.

Compensation

Explore our exceptional benefits!

Diversity, Equity and Inclusion

St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment.

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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.