Sydney Hobbs
Parkville
Summary
Enthusiastic Manufacturing Associate II eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Clear understanding of using GDP standards for Upstream manufacturing practices and working with manufacturing equipment using GMP standards. Adept at troubleshooting equipment issues and leading both on and off the floor. Experience includes working with incubators, adherent/suspension cell lines, bio reactors/iCellis systems (both large and small scale), mixers, and utilizing aseptic technique. Expertise in writing SOP revisions and Deviations, as well as conducting batch record review and batch record/SMP revisions. Motivated to learn, grow, and excel in a new position at your company. Excited to bring skills and dedication to contribute to team success.
Overview
4
4
years of professional experience
Work History
Manufacturing Associate II
Catalent Pharma Solutions
07.2021 - Current
- Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
- Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
- May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
- Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
- Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Conducts changeover and activation procedures for clean room suites and equipment
- Submits in-process and cleaning samples to Quality Control with required documentation
Manufacturing Associate
Emergent BioSolutions
10.2020 - 07.2021
- Operates manufacturing equipment such as: incubators, single-use bioreactors, single-use mixers, TFF skids and in process testing equipment
- Demonstrates aseptic technique working with cell flasks and samples
- Demonstrates, understands and adheres to GMP standards and safety procedures
- Informs Manager on process of projects, transfer of data, process details, etc
- Executes batch records according to GMP and site quality standards
- Executes manufacturing cleanroom changeover
- Supports QA during audits and regulatory inspections
- Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
Education
Master of Science - Biotechnology: Biosecurity & Biodefense
University of Maryland Global Campus
12-2025
Bachelor of Science - Microbiology, Cell Biology, Parasitology, Immunology, Genetic Analysis
Salisbury University
05.2020
Skills
- Problem solving & Troubleshooting
- Computer skills/Microsoft Office
- Written and verbal communication
- GMP laboratory procedures and aseptic technique
- SOP revisions and Deviation writing
- QA Batch record review
- MS&T Batch record revisions
- Team leadership
Timeline
Manufacturing Associate II
Catalent Pharma Solutions
07.2021 - Current
Manufacturing Associate
Emergent BioSolutions
10.2020 - 07.2021
Master of Science - Biotechnology: Biosecurity & Biodefense
University of Maryland Global Campus
Bachelor of Science - Microbiology, Cell Biology, Parasitology, Immunology, Genetic Analysis
Salisbury University
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