Melisa Morales Tudela
Broomfield,CO
Summary
With over 10 years of experience in the pharmaceutical industry specializing in biologic's, parenteral projects, and CDMO. Consistently demonstrating leadership and achieving production goals while maintaining high quality standards. Extensive knowledge of regulatory requirements and industry best practices, including GLP, GDP, cGMP, and aseptic techniques, ensuring compliance and operational excellence. Skilled at utilizing Lean Six Sigma methodologies to streamline processes and enhance efficiency within manufacturing operations. Proven track record of implementing continuous improvement initiatives that drive cost savings and improve overall productivity. Disciplined Manufacturing Supervisor looking to build upon skills and tackle new responsibilities.
Overview
10
10
years of professional experience
Work History
Manufacturing Supervisor
AGC Biologics
05.2022 - Current
- Extensive experience managing operations in both upstream and downstream process.
- Responsible for overseeing and leading large scale biotech process and equipment (including bioreactors, chromatography, TFF, buffer preparation, media, CIP, and more).
- Operational knowledge, clean room operation, purification process, recovery operations and cGMP facility regulations.
- Oversee and lead up to 8 manufacturing associate staff in the execution of production processes for GMP manufacturing operations.
- Responsible for the daily organization of workflow; delegate responsibilities for shift operations as needed.
- Establish priorities, set clear expectations, and demonstrate high standards of work practices.
- Responsible for completing the required documentation, including, but not limited to, deviation reports, change control, product changeover, and maintenance tasks.
- Monitor staff during operations as described in standard operating procedures, batch records and direct all late stage, PPQ and commercial manufacturing activities to ensure products are manufactured according to cGMP and approved procedures.
- Ensure staff complies with all company/regulatory quality systems, safety procedures, and SOPs.
- Train, coach, and mentor manufacturing team on manufacturing functions and promote a safe work environment.
- Perform MFG Final Review of manufacturing Master Batch Records (MBR) and responsible for the review and approval of executed manufacturing MBRs.
- Review and ensure errors during manufacturing operations are corrected.
- Responsible for evaluation and escalation of documentation trends for purposes of continuous improvement.
- Develop strategies for the manufacturing group to ensure a safe and compliant operation.
- Participate in cross functional meetings, customer’s meetings, and audits etc.
- Manage manufacturing activities and resolve issues to meet site goals.
- Review and approve recommendations for all process equipment / system investment applications.
- Responsible for identification of process equipment / system improvement projects to support the company operational requirements.
- Work closely with manufacturing staff in the identification of improvement projects.
- Responsible for ensuring project plan accomplishes time, quality, and cost objectives.
- Support for the investigations of deviations, corrective actions, and associated change controls.
- Responsible of approving, authorizing and reviewing, verifying and approving system records as SOPs, WOI, MPR and more.
Manufacturing Operator
Janssen Pharmaceuticals, Johnson & Johnson
02.2016 - 05.2022
- Qualified in the parenteral manufacturing operations process for lyophilized product as: Formulation, Preparation of Equipment and Components, Sanitation of Areas and Equipment, Aseptic Filling, Sealing, and Inspection with Knowledge in Aseptic Process Simulation.
- Experience with filling machines as Bosch with the Restricted Access Barrier System (RABS) and isolator syringe vial filling with Optima.
- Work following the aseptic technics and GMP in critical areas and process, knowledge of the scientific principles involved in the Parenteral Manufacturing processes.
- Collaborated with other departments to optimize production workflows.
- Collaborated and supported in activities such as validations, investigations within the manufacturing process, Gemba walk, troubleshooting, and shift changes.
- Arranged basic troubleshooting and assisted maintenance technicians in the troubleshooting of the equipment in their functional area.
- Complied with company and OSHA safety rules and regulations.
- Work in an automatized process and semi-automatized process using ArchestrA system.
- Collaborated in the process transfer of the sealing and capping process within the company, providing SME training and guidance to ensure successful implementation of new procedures.
- Designed the implementation of process improvement, documentation simplification, and safety for the daily production process, helping to reduce human error in an 85%.
- Always maintained a 97% to 100% compliance with trainings before executing any activity.
- Ensured that the control parameters of the process rooms meet 100% of the specifications before, during and after the process according to the quality standards and validated process.
- Execute Sub-process needed in equipment and areas after and before manufacturing process.
- Support in quality work, maintenance, calibrations, and validation process and equipment.
- Control of inventory with SAP system and production process. Implemented process improvements resulting in a 10% increase in production efficiency.
- Maintained strict quality control measures to minimize product rejection and ensure superior product standards.
- Mentored and trained operators to ensure precise execution of duties. Optimized production output by effectively utilizing operators' skills and expertise.
- Successfully guided operators to achieve and exceed designated production targets.
- Trained new production staff members on safe and efficient production procedures and proper equipment operations.
Associate Manufacturing
Amgen
11.2014 - 09.2015
- Experience in downstream process for large scale protein bulk manufacturing with system as TFF, Chromatography Skids, Viral Segregation (Viral Inactivation/Viral Filtration), AKTA Operations, Ultrafiltration and Diafiltration operations (UFDF), and Bulk Filling Operations.
- Preparatory, process and post process-preparatory activities. Hands-on operations, set-up, clean, sanitize per procedures.
- Execute and monitor main processes and critical operations.
- Perform sample testing such as pH, conductivity, turbidity, and Protein concentrations (solo VPE) as part of quality controls needed to continue with process.
- In-line pH probes standardization for tanks and chromatography Skids.
- Access to Citrix platform: MES and LIMS
- Execute documentation in EBR (Electronic Batch Record)
- Perform basic troubleshooting.
- Execute routine validation protocols Work with basic laboratory equipment and downstream manufacture.
- Clean, assemble/disassemble, sterilize, and operate primary process equipment.
- Complete required processing documentation including deviation reports, change control, product change over, etc.
- Ensure compliance with company quality systems, safety procedures, and other company policies.
- Ensure acceptable quality and quantity of work executed.
- Ensure that standard operating procedures are followed and are correct for bioprocess operations and equipment.
- Identified issues, analyzed information and provided solutions to problems.
- Self-motivated, with a strong sense of personal responsibility.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
Education
Bachelor of Science - Manufacturing Competitiveness
Polytechnic University of Puerto Rico
SAN JUAN, PUERTO RICO10.2022
Bachelor - Biotechnology
UNIVERSIDAD DEL ESTE
CAROLINA, PUERTO RICO05.2014
Skills
- Deviation, Root-cause analysis and CAPA management
- Functional Area Approver
- Product inspection
- Quality control system
- Employee training
- Quality inspections
- Lean manufacturing principles
- Process improvement
- MS Office
- Sharepoint
- Track wise
- ISO standards
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Manufacturing Supervisor
AGC Biologics
05.2022 - Current
Manufacturing Operator
Janssen Pharmaceuticals, Johnson & Johnson
02.2016 - 05.2022
Associate Manufacturing
Amgen
11.2014 - 09.2015
Bachelor of Science - Manufacturing Competitiveness
Polytechnic University of Puerto Rico
Bachelor - Biotechnology
UNIVERSIDAD DEL ESTE
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