Cheyenne Hill
Washington,NJ
Summary
GMP Downstream Manufacturing Operator with approximately 2 years of hands-on experience supporting commercial biologics purification in controlled cleanroom environments. Experienced in aseptic technique, downstream unit operations, in-process sampling, and GMP documentation, with a strong focus on compliance, data integrity, and contamination control in patient-critical manufacturing settings.
Overview
7
7
years of professional experience
Work History
Operator II
Celltrion Branchburg LLC – (Formerly Eli Lilly)
Branchburg Township, New Jersey
01.2024 - Current
- Support commercial GMP manufacturing of biologic drug substances through downstream purification operations.
- Perform aseptic connections, sterile transfers, and process setup in controlled cleanroom environments.
- Execute purification unit operations, including chromatography, tangential flow filtration (TFF), viral inactivation, viral filtration, and concentration/buffer exchange, per validated procedures.
- Conduct in-process sampling and testing, including A280 concentration analysis using SoloVPE.
- Utilize STARLIMS and SAP for batch documentation, material tracking, inventory control, and data traceability.
- Execute and review batch records, logbooks, and electronic documentation in compliance with cGMP and data integrity requirements.
- Adhere to environmental monitoring, gowning qualification, and contamination control standards.
- Biological Safety Cabinet (BSC) qualified, performing operations requiring heightened biosafety and procedural discipline.
- Participate in equipment cleaning, sanitization, and verification activities per validated SOPs.
- Support deviation investigations, troubleshooting, and continuous improvement initiatives.
- Support the training of new operators, and contribute to operational continuity during and after site acquisition.
Merchandise Associate
TJ Maxx
Clinton, New Jersey
11.2020 - 01.2024
- Maintained inventory accuracy and compliance with merchandising standards
- Supported fast-paced operations through teamwork and attention to detail
Certified Swing Manager
McDonalds
Clermont, Florida
10.2018 - 08.2020
- Supervised shift operations, cash handling, and staff performance.
- Ensured compliance with health, safety, and sanitation standards.
Education
Warren County Community College
WashingtonSkills
- cGMP manufacturing
- Cleanroom operations
- Aseptic technique
- Contamination control
- Batch record execution
- Data integrity (GDP)
- In-process sampling
- Process monitoring
- equipment changeovers
- SOP adherence
- STARLIMS
- SAP
- SoloVPE
Timeline
Operator II
Celltrion Branchburg LLC – (Formerly Eli Lilly)
01.2024 - Current
Merchandise Associate
TJ Maxx
11.2020 - 01.2024
Certified Swing Manager
McDonalds
10.2018 - 08.2020
Warren County Community College