PROJECT SCIENTIST

UCLA’s Department of Microbiology, Immunology and Molecular Genetics is seeking to fill a full-time Full Project Scientist position. The Full Project Scientist candidate will perform independent research on clinical trials of hematopoietic stem cell gene therapy (HSC-GT) for primary immune deficiency diseases and hemoglobinopathies. They will serve as lead for the Good Manufacturing Practice (GMP) pre-clinical and clinical production of HSC-derived cell therapy products. This will include establishment of manufacturing processes, production of essential manufacturing documents (Standard Operating Procedures, Batch Manufacturing Records, Certificate of Analysis), oversight of GMP manufacturing materials procurement and validation, management of Drug Product testing, and interacting with the UCLA Human Gene and Cell Therapy Facility (HGCTF) Quality Assurance unit and other relevant oversight. They will also participate in the development of regulatory applications and ongoing regulatory reporting. It is essential for the Project Scientist to remain up-to-date on relevant advancements in manufacturing processes by participating in relevant educational, training courses and scientific meetings. The Project Scientist position is a 12-month non-Senate position.

Specific responsibilities for this position include but are not limited to:

1. Participate in Clinical Research on stem cell gene therapy by serving as supervisor of a team working on the laboratory aspects of gene transfer clinical trials. Lead a team manufacturing cell therapy products under Good Manufacturing Practices (GMP) for Phase I/II clinical trials.
2. Participate in Process Development of new cell processing methods for new clinical trials including lentiviral vectors and various gene editing methods (CRISPR/Cas9, Base Editing, Prime Editing, etc). Develop new study protocols, batch records, and other documentation for new procedures according to requirements of the Human Gene and Cell Therapy Facility (HGCTF) quality assurance unit.
3. Ensure compliance with governing regulation for the UCLA Human Gene and Cell Therapy Facility (HGCTF), the UCLA IRB and IBC and the US Food and Drug Agency.
4. Participate in monitoring visits and audits as required.
5. Interact with HGCTF Quality Assurance members to have new protocols and documents reviewed and for Drug Product release assays results review for QA approval.
6. Provide oversight of cell product manufacturing, ordering, and maintaining inventory of supplies and reagents, equipment maintenance, and patient specimen receipt, processing, testing and storage, as well as assigning tasks to SRA 1 and SRA 2 team members and assessing personnel performance.
7. Train and supervise SRA 1 and SRA 2 team members performing cell and sample processing. Perform hands on lab work (cell processing, patient sample processing, molecular and biochemical testing), as needed to support the team.
8. Maintain lab safety standards.
9. Work with research lab staff on the translation of cell processing methods and scale-ups from the research lab to the GMP lab. Participate in the training of graduate students and post-doctoral scholars on principles and practicalities of GMP manufacturing.
10. Interact and maintain cooperative working relationships with collaborators across different departments (UCLA and non-UCLA clinical labs, research labs, hospitals) and Commercial Drug Manufacturing Organizations supporting our research and clinical trials.
11. Project Scientist will review and be responsible for records associated with all of the above duties for GMP and Good Documentation Practices (GDP) compliance and implement preventative and corrective action plans for identified deficiencies.
12. Assist with preparation of grant proposals.
13. Preparation of manuscripts for publication in scientific journals.

Minimum Qualifications:
• Ph.D. (or equivalent) in biology, biomedical science, biochemistry, molecular biology, or related field
• Expertise in Good Manufacturing Practices, Good Laboratory Practices, and Good Documentation Practices, as well as principles of Quality Assurance and Quality Control.
• 2-5 years previous experience working in a GMP laboratory required producing cell and gene therapy Drug Products.
• 1 year of supervisor experience.

Interested candidates should apply online at https://recruit.apo.ucla.edu/JPF09336.

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