Natasha Fluri
Levittown,PA
Summary
I am a hardworking and highly determined individual. Through my years of experience in the lab, ongoing education in the sciences, and consistent dedication to research, I have gladly strengthened my skills to excel in the pharmaceutical industry. I have obtained a M.S in chemistry and B.S in biochemistry. With my years of lab experience in the pharmaceutical industry and leadership skills I have gained the necessary expertise to thrive in the workplace.
Overview
5
5
years of professional experience
Work History
CAR-T Manufacturing Operator
Johnson and Johnson
09.2023 - Current
- Formulate the production of autologous CAR-T drug product for clinical and commercial operation in a controlled and current Good Manufacturing Practice (cGMP) cleanroom environment.
- Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
- Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
- Performing processes in BSC grade A, B and C lab environments.
- Use of GMP cell therapy equipment such as: Lovo, Prodigy, GatheRex Cell Harvest Pump, NucleoCounter NC-200, Centrifuge.
- A part of CAR-T Phase III expansion team.
- Senior operator for Dynamic BSC smoke study in Phase III CAR-T in reference of MBR and Environmental Monitoring Performance Qualification (EMPQ).
Quality Assurance Specialist (Contract)
Alvogen Pharmaceutical Company
08.2022 - 06.2023
- Review and approve controlled documents including standard operating procedures, master batch records, work instructions, controlled drawings, validation protocols and reports, and technical studies.
- Review and monitor stability data through internal stability software
- Provide quality oversight of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance.
- Maintain an internal quality system such as training and SOP's.
- Other experience is as followed: Root cause analysis, GMP, cGMP, CAPA, ALCOA, Investigations, Deviation, Change control, FDA regulation, Audit.
Scientist II (Contract)
Merck Pharmaceutical Company
11.2020 - 01.2022
- Independently complete vaccine related testing and composition of associated documentation, maintained instruments, coordinated instrument preventative maintenance and calibrations.
- Provided support to the biophysical scientists in the Molecular and Materials Characterization group.
- Utilized biophysical analytical characterization techniques to support research and development of vaccine drug substance and drug products in a GMP/GMP-like environment.
- Techniques used in this role are listed as follow: Particle size analysis: DLS, SLS, MFI, Flow Cytometry, Spectroscopy (Raman, IR, AUC, UV), Vaccine handling, Sterile processing.
- Utilization of strong organizational skills to maintain lab daily activities: Enable sample shipments, Conduct periodic laboratory procedures, Participate in data review as well as strong communications skills to effectively interact with MMC program representatives daily.
- Contribution to maintaining laboratory safety at all times.
QC Chemist (Contract)
Janssen Pharmaceuticals, Inc
07.2019 - 11.2020
- Provided support to the laboratory by performing assigned operational tasks such as equipment maintenance and calibration, preparation of samples and reagents, document management, etc.
- Apply SOPs and use cGMPs for documenting and maintaining an accurate laboratory notebook, including sample data for all tests performed
- Utilization of proper and timely documentation in instrument logbooks and notebooks in accordance with current SOPs
- Experience in the following programs: LIMS, Empower data acquisition software, Microsoft Office – Word, Excel, PowerPoint, Laboratory Investigation Documentation System
- Understand and follow safety procedures
- Analyze samples utilizing High Pressure Liquid Chromatography (HPLC), Ultraviolet Spectrophotometry (UV-VIS), Dissolution Apparatus
- Meeting established deadlines for all sample testing
- Daily communication with team members concerning testing, project plans, and results
- Trend results against historical data
- Identify and communicate atypical results to management and recommend corrective action
- Enter and facilitate work orders to repair equipment as needed
- Assist in the training of new analysts as directed
- Execute protocols, analyze, and document results
- Peer review notebooks
- Support sample coordinator functions when necessary.
Education
Captain -
Air Force JROTC
Swenson Arts And Technology High SchoolHigh School Diploma -
Swenson Arts And Technology High School
Bachelor of Science - Biochemistry
Harrisburg University of Science And Technology
Master of Science - Chemistry with an Emphasis in Education
Grand Canyon University
Skills
- Aseptic behavior
- Quality Assurance
- Root cause analysis
- GMP
- CGMP
- CAPA
- ALCOA
- Investigations
- Deviation
- Change control
- FDA regulation
- Audit
- Particle size analysis
- DLS
- SLS
- MFI
- Flow Cytometry
- Spectroscopy (Raman, IR, AUC, UV)
- Vaccine handling
- Sterile processing
- Strong organizational skills
- Strong communications skills
- LIMS
- Empower data acquisition software
- Microsoft Office (Word, Excel, PowerPoint)
- Laboratory Investigation Documentation System
- High Pressure Liquid Chromatography (HPLC)
- Ultraviolet Spectrophotometry (UV-VIS)
- Dissolution Apparatus
- Pipet Calibration
- Analytical Balance
- Hazardous Materials Handling
- Regulatory Compliance
- Quality Control
- Solution Preparation
- DNA isolation
- Cell transfer and seperation
- Plasmid isolation
- Agarose gel electrophoresis
- Thermal Denaturation of DNA
- High performance liquid chromatography
- Thin Layer Chromatography
- Gas chromatography
- Refractometer
- Hydrometer
- Viscometer
- PH meter
- Calorimeter
- Method Development and validation
- Animal blood handling
- DNA Purification
- HIPAA
- Assessing patients
- Making clinical judgments
- Monitoring and taking vital signs
- Advising patients on how to self-administer medication and physical therapy
- Body mechanics and positioning for patients
- Discipline
- Leadership
- Military experience
- Integrity
Accomplishments
- Research: IRB approved experimental study: Quantification of Sebum Production on Face
- Description: Conducted research at Harrisburg University of Science and Technology 'Quantification of Sebum Production on Face Compared to Skin Complexion' investigated the differences of sebum production in light and dark skin complexions through densitometric measurements. A survey was distributed to students at Harrisburg University in Harrisburg, PA. Respondents then participated in sebum collection where sebum was extracted from areas such as the forehead and cheek using Sebutape. Samples were then separated based on skin pigmentation and used for further investigation. Through method development, validating that method for sebum analysis was done for further investigation using chromatography methods.
Timeline
CAR-T Manufacturing Operator
Johnson and Johnson
09.2023 - Current
Quality Assurance Specialist (Contract)
Alvogen Pharmaceutical Company
08.2022 - 06.2023
Scientist II (Contract)
Merck Pharmaceutical Company
11.2020 - 01.2022
QC Chemist (Contract)
Janssen Pharmaceuticals, Inc
07.2019 - 11.2020
Captain -
Air Force JROTC
High School Diploma -
Swenson Arts And Technology High School
Bachelor of Science - Biochemistry
Harrisburg University of Science And Technology
Master of Science - Chemistry with an Emphasis in Education
Grand Canyon University
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