Biologic Process Development Scientist

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The School of Medicine has recently completed construction on a new GMP Good Manufacturing Practice) Facility). Our facility is a production facility for the manufacturing of cellular and gene therapy products. It includes the manufacturing space, the 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.

Reporting to the GMP Director, the Biologic Process Development Scientist will support the AAV protein, and antibody Process Development. Design, optimize and scale up biologic manufacturing processes. This role combines hands-on laboratory work with data analysis and tech transfer. Assist in bringing gene therapies from bench to clinical production.

Additionally, the Biologic Process Development Scientist will 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.

Required:

• 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

Preferred:

• 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.

Special Conditions:

• Is required to lift up to 20lbs
• Must be able to work safely with chemicals and hazardous materials
• Must be able to work overtime and flexible shifts
• Must be able to perform daily facility operation

Total Rewards

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

Conditions of Employment:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

*Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement:

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.