University of California Irvine

GMP Lead Scientist


Updated: Jan 17, 2023
Location: Irvine-Campus
Job Type:
Department: SOM Office of Research



Job Opening ID: 47999

Reports To: cGMP Manager

Working Title: GMP LEAD SCIENTIST

Department: SOM Office of Research

Bargaining Unit: 99

FLSA: Exempt

Payroll Job Code: 006832

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 manager, 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. Scientific duties include working with the manager of cGMP on the transfer and scale up of processes into cGMP manufacturing; running tech transfer and scale up runs in the cGMP suite(s); understanding and assisting in developing production batch records, including suggesting revisions and updates to SOPs related to the operation of the production equipment, facilities, cGMP utilities, and procedures to the manager of cGMP; onboarding new materials and reagents and maintain inventory for quality control use; operating cGMP manufacturing equipment and control software for buffer preparation, manufacturing of drug substances (bulk) and drug product; and ensuring cGMP manufacturing suites are cleaned and released by QA prior to initiating cGMP manufacturing campaigns. Additional managerial duties include assisting in training of appropriated cGMP staff on equipment required in the manufacturing process and supervision of staff; ensuring proper and timely completion of testing and tasks as assigned; and reviewing applications, interviews candidates and recommending individuals for hire. Administrative duties include reporting results in detailed and organized presentations and reports; collaborating with the manager of cGMP to develop, write, and revise Master Batch Production Records (MBPR); assisting with the development, writing and submission of grant proposals; participating in the development of evaluation metrics to monitor program performance; and analyzing and interpreting data, generating statistical reports and preparing program progress reports.

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.

$95,300.00 - $185,500.00 (annual)

Required:

• Ph.D. with more than 5 years of relevant experience. 2+years of experience working in GMP facility preferred
• Ph.D. in life science, biochemistry or equivalent.
• Ability to build relationships, collaborate and problem solve both internally and with external organizations. Knowledge of human resources management practices and policies. Demonstrated experience supervising staff and students in an academic or research setting. Academic background and experience in relevant area of research.
• Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders. General knowledge of GMP and GLP procedures Demonstrated knowledge of program development as well as grant proposal development and administration.
• 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.
• Demonstrated knowledge university, state, and federal policies that influence higher education. Knowledge of financial principles and budget practices.

Preferred:

• Experience in writing SOPs Experience with bioreactors; AAV and TFF Familiarity with regulatory affairs, quality control and production

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 eec@uci.edu.
Job Opening ID: 47999Reports To: cGMP ManagerWorking Title: GMP LEAD SCIENTISTDepartment: SOM Office of ResearchBargaining Unit: 99FLSA: ExemptPayroll Job Code: 006832Job Location: UCI Campus- IrvinePercent of Time: 100%Work Schedule: 8-5, M-FEmployee 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 manager, 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. Scientific duties include working with the manager of cGMP on the transfer and scale up of processes into cGMP manufacturing; running tech transfer and scale up runs in the cGMP suite(s); understanding and assisting in developing production batch records, including suggesting revisions and updates to SOPs related to the operation of the production equipment, facilities, cGMP utilities, and procedures to the manager of cGMP; onboarding new materials and reagents and maintain inventory for quality control use; operating cGMP manufacturing equipment and control software for buffer preparation, manufacturing of drug substances (bulk) and drug product; and ensuring cGMP manufacturing suites are cleaned and released by QA prior to initiating cGMP manufacturing campaigns. Additional managerial duties include assisting in training of appropriated cGMP staff on equipment required in the manufacturing process and supervision of staff; ensuring proper and timely completion of testing and tasks as assigned; and reviewing applications, interviews candidates and recommending individuals for hire. Administrative duties include reporting results in detailed and organized presentations and reports; collaborating with the manager of cGMP to develop, write, and revise Master Batch Production Records (MBPR); assisting with the development, writing and submission of grant proposals; participating in the development of evaluation metrics to monitor program performance; and analyzing and interpreting data, generating statistical reports and preparing program progress reports. 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. $95,300.00 - $185,500.00 (annual) Required: Preferred: Special Conditions Required:
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 ScanLegal Right to work in the United StatesVaccination PoliciesSmoking and Tobacco PolicyDrug Free EnvironmentThe following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.California Child Abuse and Neglect Reporting ActE-VerifyPre-Placement Health EvaluationDetails 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 eec@uci.edu.

To apply, visit https://careersucirvine.ttcportals.com/jobs/11793605-gmp-lead-scientist





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