Texas Children's Hospital Center for Vaccine Development (TCH-CVD) at Baylor College of Medicine is one of the leading vaccine development centers in the world developing low-cost effective vaccines against neglected tropical and emerging diseases that can be used in low- and middle-income countries. We are currently looking for a Research Associate who will be working within the Quality Control and Analytical Development (QC/AD) unit of the vaccine center. The Research Associate will conduct research and development activities within the QC/AD unit as well as perform the tasks within the framework of regulatory and quality system. In addition, we expect that the Research Associate will practically and intellectually contribute to complex research projects within the Division of Tropical Medicine at Baylor College of Medicine.

Job Duties

• Assists in managing the stability programs for test articles, such as vaccines and drug substances.
• Drafts, revises, approves and/or executes SOPs and other protocols and procedures.
• Responds to QA findings in lab/protocol audits.
• Participates in product and process development.
• Develops protein characterization assays such as HPLC, CD, BLI, SDS-PAGE, ELISA, Western Blot, etc.
• Designs and performs experiments, as needed, for various research projects.
• Uses instruments: HPLC, CD, BLI, UV/Vis spectrophotometer, densitometer etc., in the lab.
• Instructs laboratory members in the proper use and care of equipment and supplies.
• Documents and reviews laboratory notebook studies.
• Drafts, reviews, and/or approves technical reports.

Minimum Qualifications

• Master's degree in Basic Science or a related field. Experience in lieu of degree will not be accepted.
• Three years of relevant experience typically as a Research Assistant, Research Technician or Postdoctoral Fellow/Associate.

Preferred Qualifications

• Ph.D. new graduates will be considered.
• Master's degree in Biochemistry, Biochemical Engineering, or a related field.
• Experience in protein characterization.
• Excellent organizational, verbal and written communication skills and a demonstrated ability to work in a team.
• Basic knowledge of GxP requirements of the biotechnology industry and regulatory standards; experience in supporting the generation of regulatory submission documents.
• Familiar with techniques such as UV/Vis, SDS-PAGE, Western Blot, HPLC, Circular Dichroism, etc.
• Familiar with biologics and/or pharmaceutical development, manufacturing, quality testing and audit qualification.
• Knowledge of ICH, FDA and USP guidelines.
• Some background in GMP and GLP regulations.

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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