Geena Verna
Mountain View,CA
Summary
Enthusiastic and results-oriented professional, offering diverse expertise in the process development, manufacture, and management of clinical grade cellular therapy products according to Good Manufacturing Practices (GMP).
Overview
11
11
years of professional experience
Work History
Clinical Manufacturing Supervisor
Discovery Life Sciences
Alameda, California
08.2023 - 03.2025
- Directed clinical manufacturing operations as department lead and SME, overseeing planning, scheduling, production, validation, and delivery of clinical-grade cellular therapy products in adherence to Good Manufacturing Practices (GMP) and regulatory and industry compliances.
- Managed clinical manufacturing team of ten associates in providing extensive on-the-job technical training, featuring new hire orientation, aseptic techniques, process-specific training, cGMP documentation, and regulatory fundamentals, alongside general GLP/GDP laboratory skills.
- Directed, validated, and supervised construction of company's second cleanroom alongside all associated laboratory equipment at new site location.
- Demonstrated expertise in operating and troubleshooting essential laboratory equipment, including various cellular processing and analyzing systems like Sepax C-Pro, Cellometer K2 Fluorescent Cell Counter, and Sysmex Hematology Analyzer.
- Experienced author of equipment, general, and process-specific Standard Operating Procedures (SOPs), forms, protocols, validations, reports, and batch records.
- Engineered and executed process demonstrations and engineering runs for launch of new clinical grade products while adhering to established protocols.
- Collaborated effectively with Quality Assurance and Control, Project Management, Materials Management, Facilities, and Site Director for production and management of clinical grade cellular therapy products.
- Managed and evaluated all clinical grade documentation ensuring data entry accuracy and compliance with GDP standards.
Senior Manufacturing Associate
Discovery Life Sciences
Alameda, CA
06.2021 - 08.2023
- Launched company's inaugural clinical grade GMP program utilizing Controlled Environment Room (CER) for production of clinical grade cellular products according to both ISO and EU standards.
- Established Environmental Monitoring, Training, Gowning, Kitting, and Sanitization programs to ensure compliance with ISO and EU standards.
- Established and delivered all general and process-specific GMP master batch records, SOPs, forms, reports, and protocols to optimize overall GMP processes.
- Facilitated training and onboarding of new manufacturing associates in aseptic technique, gowning, kitting, cleaning, operation of laboratory instrumentation, and in both general and process-specific cell handling.
- Developed and manufactured clinical grade cellular products adhering to established protocols and validations.
- Translated select research grade projects, including Cryopreservation of Leukopheresis Packs, to robust clinical-grade standards.
Clinical Manufacturing Project Lead and Trainer
Minaris Regenerative Medicine
Mountain View, California
02.2019 - 06.2021
- Project lead and trainer directed teams on complex, multi-day CAR T clinical grade cellular therapy project from process development to Phase 2b clinical trials in CER for GMP processing.
- Trained and onboarded new manufacturing associates on general aseptic techniques, process-specific manipulations, and instrumentation.
- Coordinated schedules and led team of 5 manufacturing associates to maintain capacity and ensure resource availability for clinical manufacturing of client project.
- Demonstrated mastery of operational and troubleshooting skills across basic laboratory instrumentation and cell processing and analyzing systems.
- Demonstrated proficiency in cGMP documentation and regulatory standards.
Executed manufacture of clinical-grade products following established protocols and SOPs. Applied GLP and GDP principles to maintain laboratory integrity. - Executed technology transfers while engaging with clients regarding project deliverables
- Demonstrated expertise in Aseptic Cell Therapy Manufacturing and production processes.
- Authored general SOPs and process-specific work instructions with associated forms. Produced comprehensive documentation to support operational efficiency and compliance.
- Collaborated with cross-functional teams to refine manufacturing protocols.
Trained team members on updated SOPs and best practices in cell therapy. - Conducted reviews of existing documentation to ensure accuracy and relevance.
- Streamlined documentation processes to enhance clarity and accessibility.
- Maintained up-to-date knowledge of industry standards and regulatory requirements.
- Employed 6S and Kanban methodologies to uphold optimal inventory management and enhance lab maintenance
- Coordinated with Quality Assurance, Quality Control, Supply Chain Management, and Project Management to achieve successful product manufacturing for Client.
Clinical Laboratory Technician
Vibrant America
San Carlos, California
06.2018 - 01.2019
- Operated laboratory instruments for the processing of biological samples according to SOP guidelines, OSHA standards, and HIPAA regulations.
- Collaborated with Clinical Laboratory Scientists to ensure safe specimen handling and accurate patient results. Pinpointed sub-optimal specimens necessitating inspection by CLS and coordinated on tests requiring re-evaluation or cancellation.
- Maintained all machines through daily maintenance, calibrations, and quality control checks.
- Sorted and cataloged specimen tubes for efficient storage in sample racks and the online Laboratory Information System.
- Restocked, updated, and documented the inventory of both reagents and consumables for all machines.
Private Academic Tutor
Self Employed
Palos Verdes, CA
09.2014 - 06.2018
- Provided expert tutoring for students spanning elementary to college levels across various academic disciplines.
- Evaluated students' specific and shared learning requirements, developing and implementing various study plans to support student success and offered insightful feedback for growth.
- Guided students in writing concise lab reports, essays, and providing assistance with homework, projects, and test preparation.
Education
Bachelor of Science - Biological Sciences
University of California Santa Cruz
Santa Cruz06-2013
Skills
- Clinical grade cell therapy production
- Cell culture, transduction, amplification, and cryopreservation of clinical grade cellular therapy products
- GMP compliance
- GDP/GLP
- HIPAA and OSHA standards
- ISO/EU Regulatory standards
- Aseptic training and techniques
- Cleanroom operations
- SOP writing and creation
- Process development and optimization
- Equipment validation
- Quality assurance
- Project management
- Technical training
- Six sigma processes
- Root-cause analysis
- Operation and trouble shooting of general laboratory equipment as well as cell processing and analyzing instrumentation such as the Sepax C-Pro, Xuri Cell Bioreactor, CliniMACS, CliniMACS Prodigy, Lovo Cell Processing System, K2 cellometers, Sysmex Hematology Analyzer, and NC-200 NucleoCounter
References
References available upon request.
Timeline
Clinical Manufacturing Supervisor
Discovery Life Sciences
08.2023 - 03.2025
Senior Manufacturing Associate
Discovery Life Sciences
06.2021 - 08.2023
Clinical Manufacturing Project Lead and Trainer
Minaris Regenerative Medicine
02.2019 - 06.2021
Clinical Laboratory Technician
Vibrant America
06.2018 - 01.2019
Private Academic Tutor
Self Employed
09.2014 - 06.2018
Bachelor of Science - Biological Sciences
University of California Santa Cruz
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