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.Job Duties
- 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.