Full Project Scientist - Donald Kohn Lab

Details

Posted: 07-Apr-24

Location: Los Angeles, California

Type: Full-time

Salary: Open

Categories:

Academic/Faculty
Biological/Biomedical Sciences

Internal Number: 5161898

Full Project Scientist - Donald Kohn Lab
University of California Los Angeles
Requisition Number: JPF09336
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:

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.

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.

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.

Participate in monitoring visits and audits as required.

Interact with HGCTF Quality Assurance members to have new protocols and documents reviewed and for Drug Product release assays results review for QA approval.

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.

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.

Maintain lab safety standards.

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.

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.

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.

Assist with preparation of grant proposals.

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 .
Cultural North Star
The shared values of the DGSOM are expressed in the Cultural North Star, which was developed by members of our community and affirms our unswerving commitment to doing what's right, making things better, and being kind. These are the standards to which we hold ourselves, and one another. Please read more about this important DGSOM program at https://medschool.ucla.edu/cultural-north-star .
Anti-Racism Roadmap
The David Geffen School of Medicine Anti-racism roadmap is our co-created path to ensuring racial justice, equity, diversity and inclusion. We are committed to actively dismantling structural racism in our organization as described in more detail at: https://medschool.ucla.edu/diversity-anti-racism-roadmap .
To apply, please visit: https://recruit.apo.ucla.edu/JPF09336
The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. For the complete University of California nondiscrimination and affirmative action policy, see: UC Nondiscrimination & Affirmative Action Policy, https://policy.ucop.edu/doc/4000376/DiscHarassAffirmAction
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About University of California Los Angeles
UCLA is known worldwide for the breadth and quality of its academic, research, health care, cultural, continuing education and athletic programs. UCLA offers undergraduate degrees in more than 127 majors and graduate degrees in 198 program areas. UCLA has 11 highly regarded professional schools. Eight are ranked among the nation's top 15 in their field by U.S. News & World Report. UCLA is consistently among the most popular campus in the nation for undergraduate applicants. The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, national origin, disability, or protected veteran status. Benefits:UCLA offers a comprehensive benefits package, including an average of three weeks' vacation per year; an average of 12 days per year sick leave; 13 paid holidays per year; health, dental and optical benefits; life insurance; disability insurance; the University of California Retirement Plan with 5 year vesting and various voluntary UC Savings Plans. There are also special programs and privileges available, such as accessibility to cultural and recreational programs, athletic events, and the University Credit Union.
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