Carlinette Ayala
Summary
Accomplished manufacturing professional with a decade of experience in GMP-compliant environments and downstream processes within both commercial and CDMO biotechnology sectors. Demonstrates strong leadership, communication, and organizational skills, effectively managing multiple tasks and leading teams to achieve organizational objectives.
Overview
10
10
years of professional experience
Work History
Downstream Manufacturing Supervisor
Fujifilm Diosynth
08.2021 - Current
- Oversee manufacturing processes to ensure timely product release for clinical trials
- Maintain compliance with GMP standards and ensure adherence to production schedules
- Supervise operations in an aseptic environment, promoting safety through training and positive reinforcement
- Identify and implement process improvements related to material, equipment, and operational readiness
- Author and review key manufacturing documents, including work instructions, SOPs, and batch production records
- Utilize SAP for material consumption, movement, and good receipt transactions
- Review batch records and initiate deviations when necessary
- Support critical investigations, change control, and technology transfer activities
Downstream Manufacturing Technician
Fujifilm Diosynth
03.2019 - 08.2021
- Operated medium to large-scale filtration systems (TFF, HFTFF, VRF, and clarification)
- Managed chromatographic systems (ÄKTA) and single-use mixing systems (Pall & GE)
- Executed bulk filling, aseptic processing, and process simulation
- Used aseptic techniques in small and large-scale chromatography and filtration processes
- Operated production equipment (analytical scales, pH/conductivity meters, autoclaves, incubators, etc.)
- Created deviations using TrackWise and trained new team members on downstream processes
- Led downstream projects, updated SOPs, and optimized task distribution for improved efficiency
Biological Technician
AbbVie
07.2018 - 03.2019
- Managed process software (Delta V, SAP, LIMS) and monitored critical alarms
- Conducted equipment and facility inspections, sanitization of WFI & PUR systems
- Managed autoclave and glass wash operations
- Performed sampling, steam-in-place (SIP), and clean-in-place (CIP) procedures
Manufacturing Associate (Temporary)
Amgen
08.2015 - 03.2018
- Prepared buffers and media at both small and large scales
- Conducted homogenization, UFDF, and chromatography processes
- Performed SAP transactions and CIP of tanks and transfer panels
- Conducted Pall filter integrity tests and utilized aseptic techniques
- Worked with electronic batch records for manufacturing documentation
Education
Master's Degree - Public Affairs & Forensic Science
University of Turabo
Isabela, PR06.2017
Bachelor's Degree - General Science
Pontificia Universidad Católica
PR05.2015
Skills
- Leadership & Team Development
- Downstream Process Readiness
- Performance Evaluations
- GMP Compliance & Aseptic Techniques
- SAP (Materials Consumption)
- TrackWise
- Word & Excel
- Batch Records Review, GMP and GDP
- Equipment & Material Readiness
- Scheduling Process Activities
Phone - Number
787-966-9930
Timeline
Downstream Manufacturing Supervisor
Fujifilm Diosynth
08.2021 - Current
Downstream Manufacturing Technician
Fujifilm Diosynth
03.2019 - 08.2021
Biological Technician
AbbVie
07.2018 - 03.2019
Manufacturing Associate (Temporary)
Amgen
08.2015 - 03.2018
Master's Degree - Public Affairs & Forensic Science
University of Turabo
Bachelor's Degree - General Science
Pontificia Universidad Católica
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