cGMP Manufacturing Specialist - 43150-1A

Updated: Sep 22, 2022
Location: Irvine-Campus
Job Type:
Department: SOM Office of Research

Job Opening ID: 43150
Reports To: cGMP Lead Scientist
Working Title: cGMP Manufacturing Specialist
Department: SOM Office of Research
Bargaining Unit: RX
FLSA: Exempt
Payroll Job Code: 009611
Job Location: UCI Campus- Irvine
Percent of Time: 100%
Work Schedule: 8-5, M-F
Employee Class: Career
 
Position Summary:
 
The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP 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 cGMP facility will enable 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.
 
Reporting to the cGMP lead scientist, the candidate will play a key scientific role in executing the translational development strategy for the cGMP. A background in nonclinical development for gene and/or cell therapies and a proven ability to advance novel therapeutic approaches into clinical development is highly desirable. Ability to work in an independent fashion with minimum daily supervision on the manufacturing of biological products is necessary. Specific duties for cell and gene manufacturing include manufacturing GMP grade cell lines for gene therapy vector production, manufacturing, purifying, and characterizing gene therapy vectors (lenti, retro, AAV), manufacturing GMP grade human multipotent stem cells (MSCs and HSCs) and GMP grade hESC and iPSCs, performing analyses for identity and functionality on GMP grade iPSCs, hESCs and differentiated tissues using immunofluorescent stains, PCR, and other laboratory tests. Additionally, manufacturing GMP grade formulations, storing them under GMP conditions and preparing final formulations for patient administration, reviewing test results according to laboratory policy and procedure, and verifying results, monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors. Specific duties for laboratory maintenance and documentation include maintaining complete documentation as required by Federal law (21CFR 210 and 211), adhering to Standard Operating Procedures (SOPs), preparing and properly storing all incoming, intermediate and final products, performing all product manufacturing duties in the GMP facility while fully gowned, applying appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing, maintaining complete documentation throughout the manufacturing process, adhering to maintenance schedules and scheduling preventive maintenance, troubleshooting malfunctions and reporting problems, ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced, ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs, and ensuring supply inventory is maintained at appropriate levels.
 
Compensation Range:
 
$61,995 - $69,839
 
Department Website:
 
 
Required:
 
Ph.D. with more than 2 years of relevant experience. 1 year of experience working in GMP facility preferred.
Ph.D. in life science, biochemistry or equivalent.
Demonstrated experience supervising staff and students in an academic or research setting. Ability to build relationships, collaborate and problem solve both internally and with external organizations. Knowledge of financial principles and budget practices. Demonstrated knowledge university, state, and federal policies that influence higher education. 2+ years of aseptic cell culture (human primary cells and/or human cell lines) is required. Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution. General knowledge of GMP and GLP procedures. Demonstrated knowledge of program development as well as grant proposal development and administration. Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders. Quality Control Assays Experience (e.g., qPCR, Flow Cytometry, Elisa, etc.). Academic background and experience in relevant area of research. Knowledge of human resources management practices and policies.
 
Preferred:
 
Experience with bioreactors; AAV and TFF Familiarity with regulatory affairs, quality control and production Experience in writing SOPs.
 
Special Conditions Required:
 
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.
 
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
  • Legal Right to work in the United States
  • Vaccination Policies
  • Smoking and Tobacco Policy
  • Drug Free Environment
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, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination 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 [email protected].

 

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