Biologic Process Development Scientist

University of California, Irvine•Irvine, CA

1d•Onsite

About The Position

UC Irvine is a member of the Association of American Universities and is ranked among the nation’s top 10 public universities. The School of Medicine has recently completed construction on a new GMP (Good Manufacturing Practice) Facility, which is a production facility for the manufacturing of cellular and gene therapy products. This facility includes manufacturing space, a storage warehouse for raw and finished product, and support laboratory areas, including quality control laboratory and quality assurance department, to control collection, processing, storage, and release of cell therapy products. At UCI, the GMP facility will enable clinical trials of cell and gene therapeutics, including viral vector productions, stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.

Requirements

Academic background and experience in relevant area of research.
Ability to build relationships, collaborate and problem solve both internally and with external organizations.
Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
Demonstrated knowledge university, state, and federal policies that influence higher education.
Familiarity with regulatory affairs, quality control and production
Experience in writing SOPs and Batch Record
Quality Control Assays Experience (e.g., qPCR, Flow Cytometry, Elisa, etc.).
Development, optimization, and validation of analytical assays
Development, optimization, and validation of analytical assays.
Master’s or PhD in molecular biology, microbiology, biochemistry, or related science/engineering field.
Prior experience working in an aseptic environment, biosafety cabinet and working with human tissues required.
2+ years Flow Cytometry (staining, acquisition, and analysis).
2+ years of aseptic cell culture (human primary cells and/or human cell lines)
1-year General knowledge of GMP and GLP procedures
Must be able to provide proof of work authorization

Nice To Haves

Demonstrated experience supervising staff and students in an academic or research setting.
Demonstrated knowledge of program development as well as grant proposal development and administration.
Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
Knowledge of human resources management practices and policies.
Knowledge of financial principles and budget practices.
Environmental Monitoring Testing
Experience with maintenance of analytical and retain sample inventory logs under GMP compliance.
Experience in stability testing and environmental monitoring.
2 years of experience working in GMP facility or industrial scientific setting.

Responsibilities

Support the AAV protein, and antibody Process Development.
Design, optimize and scale up biologic manufacturing processes.
Combine hands-on laboratory work with data analysis and tech transfer.
Assist in bringing gene therapies from bench to clinical production.
Review, revise, and develop standard operating procedures (SOPs) as needed.
Maintain up-to-date knowledge of regulatory requirements, lab technologies, and attend relevant training and conferences.
Maintain complete documentation as required by Federal law (21CFR 210 and 211) and adhere to Standard Operating Procedures (SOPs).
Adhere to maintenance schedules and schedules preventive maintenance, troubleshoot malfunctions and report problems, repairs critical parts of equipment (such as media and fluid pumps, centrifuge, autoclave issues, etc.) designated for certain manufacturing processes and resolve unscheduled maintenance problems.
Ensure that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced.
Ensure that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs.
Ensure the work areas are kept clean, neat and orderly as needed for GMP compliance and supply inventory is maintained at appropriate levels.