Hannah Lombardo
Bridgewater
Summary
Dynamic Cell Processing Specialist with extensive experience at Dana-Farber Cancer Institute, excelling in cGMP compliance and operational efficiency. Proven track record in implementing workflow processes and enhancing cross-departmental communication. Skilled in aseptic cell processing and regulatory documentation, ensuring the highest standards in cellular therapy product management.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Cell Processing Specialist, Stem Cell Transplant Lab
Dana farber cancer institute
09.2024 - Current
- Perform aseptic cell processing for allogeneic and autologous products in a ISO 7 cleanroom environment.
- Perform preparation, cryopreservation, and thawing of cellular therapy products including DLI and CAR-T under cGMP conditions.
- Work within the cGMP and cGTP guidelines and adhere to all regulatory standards.
- Maintaining competency while creating and reviewing batch records.
- Proficient in clinical systems such as EPIC, Sunquest, Biotherapy, Hematrax, MasterControl, LIMs.
Clinical Trial Med Tech
Dana farber cancer institute
08.2019 - 09.2024
- Responsible for the accessioning, processing, tracking, and storage of all research specimens.
- Utilizes protocol-driven standard operating procedures for the processing of pharmacokinetics, pharmacodynamics and biomarker samples.
- Responsible for implementing and enforcing highest standards of specimen handling and processing with compliance to SOPs and regulations.
- Experience reviewing protocol applications and amendments for laboratory feasibility through OncPro and OnCore.
- Created and implemented workflow processes for new satellite lab as well as proposed initiatives identifying potential workflow roadblocks and developed SOPs.
Research Technician
Dana farber cancer institute
08.2017 - 08.2019
- Assisted lead scientist in preparing reagents and media in addition to managing laboratory needs.
- Performed mammalian cell culture as well as protein purification for western blot analysis.
Education
MBA - Healthcare Management
Fitchburg State university
Fitchburg, MA09.2024
BS - Biology
Fitchburg State university
Fitchburg, MA01.2017
Skills
- Problem solving
- Cross-departmental communication
- Workflow management
- Process implementation
- Operational efficiency
- Cleanroom operations
- Cell processing
- Mammalian cell culture
- CGMP compliance
- SOP adherence
- Batch record management
- Regulatory documentation
- Deviation reporting
- Regulatory compliance
- Cell culture techniques
Certification
Project Management Professional Certification, Current
Timeline
Cell Processing Specialist, Stem Cell Transplant Lab
Dana farber cancer institute
09.2024 - Current
Clinical Trial Med Tech
Dana farber cancer institute
08.2019 - 09.2024
Research Technician
Dana farber cancer institute
08.2017 - 08.2019
MBA - Healthcare Management
Fitchburg State university
BS - Biology
Fitchburg State university
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