Project Scientist - DBK University of California, Los Angeles
Requisition Number: JPF04612 Recruitment Period Open May 22nd, 2019 through Wednesday, Jun 19, 2019 at 11:59pm (Pacific Time)
The Project Scientist candidate will perform translational research on gene editing for genetic diseases of blood cells (especially Sickle Cell Disease), with a specific focus on leading the research group performing IND-enabling studies in the research and MOP labs. The Project Scientist will be responsible for supervising SRAs 1-3, post-doctoral fellows, graduate students and undergraduate student researchers and for publishing manuscripts for scientific journals. This position requires a Ph.D. in Microbiology or the equivalent discipline, extensive knowledge of principles of Good Manufacturing Practice (GMP) for the compliant performance of clinical trials of investigative cell and gene therapies and at least 5 years of experience in CRISPR-mediated gene editing in hematopoietic stem cells, molecular biology, experimental hematology, and compliant performance of early phase clinical trials. The incumbent must have experience in writing scientific manuscripts and research protocols, SOPs and other documents. The Project Scientist position is a 12-month, non-Senate position.
Interested candidates should apply on-line by June 18, 2019 on this site:
Starting Date: July 1, 2019 or as soon as mutually agreeable.
Specific Responsibilities include:
Gene editing hematopoietic stem cells (HSC) has the potential to provide more effective and safe approaches to the treatment of genetic diseases of blood cells, to engineer the immune system to be resistant to HIV-1, and to direct immune effector cells against cancer and leukemia. Substantial progress has been made over the past 30 years, and techniques to edit genes in HSC are now ready to be moved to early phase clinical trials. These new approaches can be evaluated in pre-clinical cell culture and animal models, but ultimately must be assessed in well-designed and carefully performed clinical trials.
The Project Scientist will be responsible for leading these pre-clinical studies to lead to an IND application to FDA to perform a Phase I/II clinical trial. Extensive knowledge of gene editing technology applied to hematopoietic stem cells, and translation of these methods to clinical applications for the proper conduct of clinical trials using investigational reagents under Federal, State and University guidelines is mandatory. Additionally, a strong knowledge-base in molecular biology, gene editing, stem cell biology and the according experimental methods is required for this effort. A major focus of the research of this Project Scientist will be to lead the performance of IND-enabling studies of gene editing cell processing, as well as assembly of the IND components, including clinical trial documents, regulatory applications and reports from Pharmacology/Toxicology studies, the submission of these protocols to the multiple regulatory entities that oversee these trials, and for overseeing the data management, documentation and regulatory reporting that is required.
The specific objectives of the project are:
Direct lab and GMP la studies of gene editing in HSC for sickle cell disease,
Develop the necessary clinical trial protocols, informed consent and other essential documents for clinical trials
Develop essential case report forms and data monitoring plans
Apply to all governing regulatory agencies and boards for approval for the trials.
Coordination of gene editing project across three collaborative sites: UCLA, UCSF, and UCB to ensure harmonization of efforts.
Prepare quarterly project reports to CIRM
Oversee performance of GLP toxicology study at Contract research Organization and ensure final report meets FDA requirements.
Oversee performance of GMP cell processing runs to support CMC component of IND
Oversee development of clinical trial protocol with project physicians and associated documents, such as Informed Consent, Investigator's Brochure, and Case Report Forms.
Compile components of IND to FDA
Supervision of Staff Research Associates I-III, undergraduates and graduate students and new postdoctoral trainees in the lab.
Ability to work on multiple projects efficiently and effectively.
Ability to work independently on scientific projects.
Assist with preparation of grant proposals, as needed.
Preparation of manuscripts for publication into scientific journals.
Required to communicate well with other scientists, regulatory personnel, biotech companies, Sponsored Research Organization, personnel worldwide.
Candidate should have at least 5 years research experience in molecular biology in an academic setting or equivalent as well as extensive knowledge of the principles of Good Manufacturing Practice (GMP) and the compliance issues that govern clinical trial cell processing using experimental reagents.
Should have extensive experience in cell culture and all types of cell biology and molecular biology, immunofluorescence/flow cytometry and biochemical techniques.
Unique and specialized knowledge and skills are required to work with human hematopoietic stem cells that includes but is not limited to HSC cell culture, isolation of nucleic acids and proteins, development and characterization of GMP gene editing reagents, and application of appropriate analytic methods (e.g. flow cytometry, PCR, next generation sequencing, etc.).
The candidate will report directly to the Principal Investigator.
The candidate will also provide support in publishing the results of various projects.
The candidate will share responsibility in the general management and supervision of personnel in the laboratory.
The candidate will be responsible for ensuring that all laboratory equipment in working order and maintained per Quality Management plan.
Ongoing maintenance of necessary licensure, certifications and continual education are essential.
The candidate will be required to complete all appropriate safety training as mandated by the campus's Environmental Health & Safety Office
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 and Affirmative Action Policy.
University policy is intended to be consistent with the provisions of applicable State and Federal laws.
The Department is Particularly interested in candidates who have experience working with students from a diverse background and a demonstrated commitment to improving access to higher education for disadvantaged students or The (School) at UCLA is committed to building a more diverse faculty, staff and student body as it responds to the changing population and education needs of California and the nation.
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
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.
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.