The Research Associate for Cell and Gene Therapy will work  on assay development for characterization of cell therapy products; production and testing of retroviral producer clones; process development for Cell therapy products; ensure compliance and quality control of GLP assays performed by research labs and assist with CMC section of IND.

• Identify, qualify and validate bioassays and molecular methods
• Plasmid design, producer line transfection, producer clone selection and characterization, submission to vector production lab for manufacture
• Work with investigators to bring their research production into GMP compliance, write SOPs and worksheets for production
• Implement training of research staff on GLP assays and maintain training records
• Review GLP batch records for patient follow up sample analysis
• Improve the organization and efficiency of GLP procedures
• Write and review CMC sections, provide guidance for PrincipaI Investigators in CMC preparation and on the preclinical work required
• Provide training seminars
• Organize seminar series on current and new protocols to GMP and QA/QC staff
• Identify improved technologies for GMP and GLP

• 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.

• PhD in Biomedical science
• Experience in GMP, GLP and quality assurance
• Ability to communicate well, including oral and written communication
• Good people skills

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.

 13775