Nina Mandic
Hermosa Beach,CA
Summary
Dynamic Quality Assurance Operations Manager with a proven track record at ImmunityBio, Inc., excelling in regulatory compliance and team leadership. Spearheaded the implementation of new product lines, driving continuous improvement and achieving notable employee retention. Expert in project management and adept at fostering a risk-based approach to enhance operational efficiency.
Overview
14
14
years of professional experience
Work History
Quality Assurance Operations Manager
ImmunityBio, Inc.
Culver City, CA
03.2022 - Current
- Manage disposition of Autologous M-CENK, a unique patient-specific therapy with shortest disposition window
- Oversee the implementation of new product lines at the Culver City Manufacturing Facility with risk-based approach to begin GMP Manufacturing
- Drive success of Quality Systems by maintaining on-time closure of risk assessments, CAPAs
- Enhanced efficiency by driving Continuous Improvement initiatives
- Achieved high level of employee retention across the team. Retained longest standing employee for 5 years and shortest standing for 3 years.
Quality Assurance Supervisor
ImmunityBio, Inc.
Culver City, CA
08.2019 - 03.2022
- Collaborated with other departments to resolve issues related to product quality.
- Collaborated with stakeholders to identify, investigate, and verify complex records and potential risk issues.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Worked closely with R&D, Manufacturing, Supply Chain, Engineering/Validations, and Quality Control to implement new product lines
Microbiologist Lead
Kite Pharma
El Segundo, CA
01.2018 - 05.2019
- Approved of Environmental Monitoring reports to support commercial product and clinical product release
- Approved Quality Control Microbiology reports for Sterility, Bioburden, Endotoxin, and Gram Stain testing to support product release
- Led training of new hires
- Enhanced efficiency of EM program to utilize resources for other activities
Quality Control Sr. Microbiologist
Oakwood Laboratories
Solon, OH
08.2011 - 09.2017
- Directed Media Fill Program operations for sterile liquid formulations in a contract manufacturing organization.
- Managed environmental monitoring processes to maintain regulatory adherence.
- Oversaw internal audits and ensured compliance with regulatory standards.
- Led method validation for raw materials testing, drug substance, and final product
- Developed new procedures and guidelines for operations.
- Authored investigations and risk assessments
Education
Bachelor of Science - Biology
Bowling Green State University
Bowling Green, Ohio05-2011
Skills
- Project management
- Continuous improvement
- Regulatory compliance
- Team leadership
- Problem solving
- Risk-based approach
References
References available upon request.
Timeline
Quality Assurance Operations Manager
ImmunityBio, Inc.
03.2022 - Current
Quality Assurance Supervisor
ImmunityBio, Inc.
08.2019 - 03.2022
Microbiologist Lead
Kite Pharma
01.2018 - 05.2019
Quality Control Sr. Microbiologist
Oakwood Laboratories
08.2011 - 09.2017
Bachelor of Science - Biology
Bowling Green State University