Cynthia Kim
Lowell
Summary
Seeking a position to utilize my knowledge, skills, and abilities in the industry that offers a competitive environment, a true profession to put in the acquired knowledge and gain exposure to upcoming technologies while being resourceful, innovative, and flexible. Extremely familiar in working with Standard Operating Procedures (SOPs) and maintaining Current Good Manufacturing Practice (cGMP) regulations.
Overview
5
5
years of professional experience
Work History
QC Data Reviewer
Sarepta Therapeutics
06.2023 - Current
- Review protocols, raw data packets, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, cell-based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta.
- Monitor, compile, and review analytical and QC data individually and with team members.
- Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
- Assist with Freezer works (Sample Management inventory system), Sample submission and receiving paperwork, and support shipping of critical material (DOT/IATA training to be provided).
- Create and maintain clear, concise records and documentation.
- Trend data for qualified materials, release products, and stability products.
- Perform other related duties incidental to the work described.
Reagent Manufacturing Associate
Vizgen
09.2022 - 05.2023
- Developing and implementing Lean Manufacturing techniques to improve quality, cost, and delivery of products, including improvements in workplace organization/5S, daily production meetings and production workflow.
- Creation of effective manufacturing documentation and production records (Work Instructions, SOP's QCP's, Batch Records)
- Assisting with equipment and process validations and new product/process development.
- Reagent Formulation and filling
Manufacturing Technician II
Takeda Pharmaceuticals
12.2021 - 08.2022
- Prepared standard operating procedures, manufacturing batch records, and productivity reports.
- Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
- Record data into logbooks and conduct sample preparation and testing.
- Initiate work orders and perform schedules cleaning and standardization of equipment.
- Compliance with SOPs/GMP/GDP standards.
Manufacturing Technician
AbbVie
08.2021 - 12.2021
- Operation small/large cell culture areas and systems by operating, cleaning, setting up, and maintaining batch feed fermenters; Inoculating and maintaining seed cultures using an aseptic technique; and performing general seed lab operations.
- Operating fermenters, centrifuges, and other harvest systems.
- Completes tasks in resourceful and effective ways.
- Works on assignments requiring considerable judgement and initiative.
- Understands implications of work and makes recommendations for solutions.
Quality Control Inspector
Bae Systems Inc.
10.2018 - 07.2019
- Updated quality control records and reports.
- Inspected quality of products, taking note of functionality, appearance and other specifications.
- Used tools such a fine-tipped tweezers, dental probes, high powered microscopes, calipers, and other microelectronics assembly inspection tools.
- Performed kit inspection, pre-test inspection of high-reliability microelectronics devices and active/passive components in a clean-room environment.
- Understands implications of work and makes recommendations.
- Read and interpret assembly instructions, drawings, and work instruction processes.
Education
Associate of Science - Biotechnology
Middlesex Community College - Bedford
Bedford, MA01.2023
High School Diploma -
Lowell High School
Lowell, MA06.2017
Skills
- Equipment preparation (CIP/SIP)
- Cell culture (from vial thaw to production scale)
- Media Preparation
- Column Chromatography
- Tangential Flow Filtration
- Proficient in mammalian cell culture and aseptic techniques
- Excellent attention to detail and ability to communicate
- RNA/DNA reagent manufacturing
- Lean manufacturing principles
Timeline
QC Data Reviewer
Sarepta Therapeutics
06.2023 - Current
Reagent Manufacturing Associate
Vizgen
09.2022 - 05.2023
Manufacturing Technician II
Takeda Pharmaceuticals
12.2021 - 08.2022
Manufacturing Technician
AbbVie
08.2021 - 12.2021
Quality Control Inspector
Bae Systems Inc.
10.2018 - 07.2019
Associate of Science - Biotechnology
Middlesex Community College - Bedford
High School Diploma -
Lowell High School
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