Process Development Lead 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 Facility, following current Good Manufacturing Practices (GMPs). A GMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the GMP facility enables clinical trials of cell therapeutics, including 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, and a newly-established process development lab.

The Lead Scientist of the UCI Cellular Therapies Process Development (PD) Program will have a broad range of responsibilities that maintain the viability of these new facilities for the development, scale up, and production of cellular therapeutics. This program will serve the University of California at Irvine community and extramural organizations. The PD Manager will have direct oversight of all aspects of process development for novel gene and cell therapy products.

The PD Lead Scientist will report administratively to the GMP Facility Director. Oversight and direction will also be provided by the Medical Director, other leadership, and the Cell and Gene Therapy Oversight Committee. This reporting structure is consistent with the expectation that the GMP and the cell processing laboratories will cooperate to support investigators across the entire biomedical spectrum residing within multiple UCI academic units, will of necessity interface with UCI Health, and will have significant extramural contracted use. The Lead Scientist must act with professionalism, efficiency, strategic thinking, creative problem-solving, appropriate communications, and strong time-management, prioritization, and project management skills to oversee the dynamic activities associated with an academic GMP facility.

Required:

• Adherence to excellent customer service principles.
• Organizational skills sufficient to prioritize duties in an ever-changing environment.
• Must possess technical vocabulary to meet facility needs.
• Must possess knowledge of medical terminology, basic human anatomy, chemistry, biology and molecular biology and technical knowledge to complete assigned tasks.
• Ability to listen, collect information, and give instructions in an effort to support, clarify, or resolve problems.
• Knowledge of personal computer, word processing, data management, and spreadsheet software.
• Knowledge of standard precautions and biosafety. Knowledge of Occupational Safety and Health Act (OSHA) and laboratory safety regulations.
• Outstanding written and oral communication skills. Ability to lead discussions, to particulate test procedures, and to make effective presentations. Utilize effective listening and questioning techniques.
• Must be able to write clear technical reports in the scientific format. Must be able to maintain logs and documentation in the same manner.
• Maintains appropriate interdepartmental communication.
• Tact and diplomacy skills to meet the needs of a highly interactive position.
• Ability to work well under pressure to meet commitments and to remain flexible with a variety of changing demands.
• Ability to manage several projects or tasks simultaneously and to exercise appropriate judgment when prioritizing projects of assignments.
• Ability to work as a member of a team and to assist colleagues as needed.
• Ability to function and work in a diverse work environment.
• In depth knowledge of GMP laboratory policies and procedures as documented in SOPs
• Teaching and communication skills necessary for interactions with students, and postdoctoral fellows.
• Knowledge of federal and state legislation and regulatory requirements pertaining to the GMP laboratory and CMC documentation.
• Ability to work in full body suit and with face mask and gloves for hours in a controlled environment, such as a clean room (GMP) facility.
• Experience with process characterization, scale-up, and technology transfer.
• Ability to work effectively in a matrix environment and gain buy-in from stakeholders.
• Advanced degree in related area and / or equivalent experience / training.
• At least 5 years of experience in research roles with progressively complex responsibilities
• Previous experience in a managerial function

Preferred:

• Terminal degree in a related field (PhD, MD, etc.) preferred but not required.
• Experience working in a GMP facility, focusing on process development and manufacturing of cellular therapy products is preferred
• Previous experience managing in vivo studies to support the development of novel cell therapies, including assisting with experiment design is preferred

Special Conditions:

• Experience in or knowledge of GMP production procedures and facilities is preferred. Alternatively, the candidate must be willing to be trained for a period of at least 3-6 months in a GMP facility with extensive experience in cell manufacturing.

Total Compensation

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.