Gustavo Caetano Costa
Clark
Summary
Dynamic Cell Processing Specialist with extensive experience at Novartis, skilled in aseptic techniques and environmental monitoring. Proven ability to optimize workflows and train new employees, ensuring compliance with cGMP regulations. Adept at using automated equipment and maintaining cleanroom protocols, contributing to successful batch production and operational excellence.
Processing specialist with strong attention to detail and problem-solving skills. Proven ability to meet deadlines and adapt to changing requirements. Known for effective team collaboration and delivering consistently high-quality results. Skilled in data analysis, process optimization, and regulatory compliance, ensuring operational efficiency and accuracy.
Overview
4
4
years of professional experience
Work History
Cell Processing Specialist 2
Novartis
10.2020 - Current
- Gowned in Qualified ISO 8, 7, and 5 cleanroom environments and stand for long period of time.
- Skilled in cell washing with automated equipment. Such as Prodigy, CS5, Centrifuge, LOVO, NC200, Wave Bioreactor
- Trainer Qualified
- Experienced in Maintaining and preparing equipment/environment for use.
- Experienced with related IT systems like SAP, LIMS, MES
- Responsible for on-time completion of training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE
- Works with chemicals such as SPORKLENS, IPA, Hypochlorite.
- Experienced with processing/verification of media lots, Kymriah, Red apple with top-level aseptic technique
- Qualified for Environmental Monitoring
- Knowledge of cGMP regulations and FDA guidance applicable to biologic and cell therapy manufacturing.
- Experience with Aseptic processing in ISO 5 biosafety cabinet.
- Coordination of receiving, storage and processing of materials and ensure proper status segregation and storage of all conditioned and ambient materials.
- Experienced with taking Red apple samples. Such as APH flow, D3 VSVG, ENT Flow, Red apple harvest samples, D0 kmyriah samples, Harvest kmyriah samples.
- Trained new employees on areas of technical expertise and compliance issues
Education
CRST Certification -
Berkely College
01-2017
Skills
- Standard operating procedures
- Operational excellence
- Document review
- Workflow optimization
- Data entry
- Customer service
- Cleanroom protocol expertise
- Environmental monitoring
- Batch production records management
- Problem solving and critical thinking
- Sterilization procedures proficiency
- Aseptic technique
Languages
Spanish
Full Professional
Portuguese
Native or Bilingual
Timeline
Cell Processing Specialist 2
Novartis
10.2020 - Current
CRST Certification -
Berkely College
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