Job Description

Requisition Number 05912
Department Name: Calibr
Position Type: Full Time
Position Title Head of Cellular Manufacturing (Calibr)
Position Summary:

Job ID: N157. This position is with the California Institute for Biomedical Research (Calibr). To learn more about this opportunity and/ or to apply for consideration, please go to https://www.scripps.edu/science-and-medicine/calibr/careers/

The California Institute for Biomedical Research (Calibr) is a not-for-profit research institute located in La Jolla, California. Calibr is focused on innovative early-stage translational research in the areas of regenerative medicine, cancer biology, cardiovascular and metabolic disease, immunology and infectious disease.

Position Overview:
This position will lead cellular manufacturing efforts within a team of interdisciplinary scientists to translate novel cellular therapies for the treatment of cancer into human clinical trials. Specifically, this position will be integral in the translation of a universal, switchable CAR-T cell platform into first in human clinical trials. The Senior or Principal Scientist will be responsible for in-house process development of cellular manufacturing, integration with analytical development and qualification, and tech transfer to, and management of, external work with contract organizations, as well as in defining the program’s manufacturing & supply strategy.

Essential Duties and Responsibilities:
* Lead the cellular manufacturing process development for a first-in-human CAR-T cell therapy clinical trial
* Manage CMC development, manufacturing, quality, and supply chain projects to support clinical development
* Collaborate closely with our cutting-edge basic research teams to translate protocols and scale processes to GMP
* Author technical and scientific documents including SOPs, review Master Batch Records, study protocols, and reports.
* Hands-on, wet lab experiments, and training of personnel are within the scope of work, including cell culture, cell isolation, lentiviral transduction, and cryopreservation
* Design process development experiments, including DOE, process scale-up, the operation of related equipment, and the development and incorporation of appropriate analytical testing
* Management of CROs and CMOs in cellular manufacturing and analytical development
* Prepare and author detailed protocols, reports, and CMC documentation to support regulatory filings

Location: California
Additional Information:

This position is with the California Institute for Biomedical Research (Calibr). To learn more about this opportunity and/ or to apply for consideration, please go to https://www.scripps.edu/science-and-medicine/calibr/careers/

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

Details of established essential functions for this position will be addressed/discussed during the interview process

Basic Qualifications:

* Hands-on, deep experience with cellular manufacturing and thorough understanding of CMC related to CAR-T cell therapies is essential
* Experience with process scale-up is required
* Experience with close, automated manufacturing systems is strongly preferred
* A strong background in cell culture is essential
* Experience and knowledge of the immune system are a required.
* Experience in T cell biology, tumor immunology, as well as other immune components is preferred.
* Knowledge of compliance and quality management systems is required.
* Knowledge in flow cytometry and T cell phenotyping is strongly preferred.
* Experience with cell transfection and transduction systems is preferred.
* Experience using Prism, FlowJo, and Office software are important.
Qualifications:
* MS, or Ph.D. in biology, chemical biology, biochemistry or related area with 8-12+ years’ experience in industry (minimum 5+ years’ direct experience in CAR-T cell),
* Impeccable attention to details, and excellent ability to perform hands-on experiments, research, design, and organize project designs and maintain detailed documentation.
* Highly motivated, creative, and devoted to project goals.
* Able to collaborate proficiently and communicate effectively with colleagues and management teams.
* Able to contribute in a meaningful way to scientific discourse.

Preferred Qualifications:
Compensation: Commensurate with experience
Job Closing Date:
Open Until Filled Yes
Job Posting Category Scientific & Technical
EEO Statement

The Scripps Research Institute is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.

Application Instructions

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