FELIX MONTES
Caguas,USA
Summary
16 years of experience in the Biopharmaceutical and Pharmaceutical industry. Possess extensive experience as an employee in a world-class process manufacturing environment in the production of life saving medications. Knowledge of manufacturing process, including full exposure, and corresponding training to GMP guidelines, Health, Safety and security. Biotechnology associate degree. Bachelor’s degree Information technology with major in software analysis & development. Master’s degree in business administration with major in planning & strategy.
Overview
17
17
years of professional experience
Work History
Production Supervisor
West Pharmaceuticals
Cayey
2024.12 - Current
- Created detailed reports outlining progress on various projects.
- Trained new staff on production processes and procedures.
- Assisted with troubleshooting equipment malfunctions or operational problems as needed.
- Supervised a team of 20+ employees, ensuring tasks were completed efficiently and accurately.
- Conducted regular performance reviews for each employee to identify areas for improvement.
- Ensured safety regulations were followed by all personnel in the production area.
- Monitored equipment, checked supplies and coordinated manpower to meet expected demand.
- Observed and monitored utilization of equipment.
- Identified needs of customers promptly and efficiently.
- Provided feedback and guidance to personnel regarding their job performance and development plans.
- Managed daily operations within budget constraints while meeting deadlines.
- Recommended and implemented measures to improve production methods and quality of products.
- Planned production operations while establishing priorities and sequences for manufacturing processes.
- Communicated effectively with other departments to ensure smooth workflow from start to finish.
- Conducted performance reviews to identify and rectify areas for skill improvement.
- Prepared operations data to produce comprehensive reports to management.
- Planned and developed new operation processes to innovate and stay competitive.
- Cultivated communication among senior managers and floor supervisors to encourage optimal productivity.
- Directed and coordinated production activities, encouraging employees to meet specifications.
Production Supervisor
Thermo Fisher Scientific
Manati, PR
2024.09 - 2024.12
- Responsible for leading all aspects of operations with general responsibility for safety, quality, delivery, and cost daily, while leading a team of up to 25 employees
- Lead and supervise a team of manufacturing personnel to ensure flawless execution of production schedules and adherence to quality standards
- Collaborate with cross-functional teams to determine manufacturing priorities and successfully implement production plans
- Maintain quality system by following SOP's and work instructions and update as needed
- Promote Practical Process Improvement (PPI) to achieve cost savings goals
- Drive continuous improvement initiatives to optimize manufacturing processes and increase efficiency
- Supervise production metrics and analyze data to identify areas for improvement and implement corrective actions
- Ensure compliance with safety regulations and company policies in the manufacturing area
- Train and develop team members to enhance their skills and competencies
- Ensure Employees are following company policies and performance manager when vital
- Maintain the staffing plan and develop a highly productive and efficient team
Merck Animal Health
Millsboro, DE
2021.10 - 2024.09
- Responsible for packaging responsibilities and adjunct support at times required for managing media preparations, sterile equipment preparations, and responsibilities within the Media, Central Services, and Warehouse Departments as required
- This position will ensure that production schedules are met in accordance with all safety procedures and standard operating procedures to meet company product quality standards
- Supervision of facilities, equipment, and personnel in focusing in Packaging, and adjunct support to WH, Media Production and Central Service departments
- This would include coordination of additional labor, such as temporary employees or other departments
- Review and revise processes and procedures against corporate and regulatory requirements to ensure compliance
- Review production records for completeness and compliance to departmental and/or Site SOPs
- Provide training to personnel to stay current with all regulatory agencies and corporate policies
- Evaluate personnel and machinery requirements and make and/or implement recommendations for changes and improvements
- Participation in daily activities to understand requirements and issues
- Provide guidance to personnel to maximize through-put while meeting regulatory requirements
- Coordination with venders to determine equipment options
- Assist with capital projects
- Assist in the purchase of new equipment, FAT’s, SAT’s, OQ, PQ
Production Lead (Acting Supervisor)
Jubilant Cadista
Salisbury, MD
2019.06 - 2021.10
- Lead and supervise operations in compliance with the SOP’s, cGMP’s and Quality Standards
- Train, direct and develop hourly employees
- Overseeing a team of sixteen operators for the performance of all necessary tasks within the classified areas for the manufacture of safe and effective tablets
- Responsible for training and mentoring of new or less experienced Operators, assist in the development and execution of equipment and process qualification, validation, protocols and standard procedures
- Ensure that daily production is running efficiently
- Responsible for scheduling of Operators to meet the needs of the department
- Review’s documentation generated by the Operators for completeness and facilitates necessary corrections and reinforcement training
- Participate in investigations and execute appropriate approved corrective/preventative actions (CAPA) for classified area related processes
- Experience as: Downstream (solid dosage/tablets), Coating, Compression, Blending, Granulation, screening
Biologic’s Operator ll
AbbVie
Barceloneta, PR
2014.11 - 2019.06
- Execute Biotechnologies operations in compliance with the SOP’s, cGMP’s and Quality Standards
- Train, direct and develop hourly employees
- Define and implement new methods of production to improve efficiency
- Overseeing a team of eight operators for the performance of all necessary tasks within the classified areas for the manufacture of safe and effective sterile biological products
- Set-up, operation, and troubleshooting of manufacturing equipment
- Responsible for training and mentoring of new or less experienced Operators, assist in the development and execution of equipment and process qualification, validation, and protocols, ensure that daily production is running efficiently
- Responsible for scheduling of Operators to meet the needs of the department
- Reviews documentation generated by the Operators for completeness and facilitates necessary corrections and reinforcement training
- Participate in investigations, and execute appropriate approved corrective / preventative actions (CAPA) for classified area related processes
- Experience as: Downstream, Purification: Humira (Adalimumab) Entivyo (Vedolizumab), Chromatography column’s (Q-sepharose Fast Flow, SP-sepharose, CHT, Phenyl), Ultrafiltration (Concentration, Diafiltration), Viral filtration, PH Adjustment, Final Bottling
Biotech Op.
Eli Lilly.
Carolina, PR
2011.08 - 2014.11
- Execute Biotechnology operations in compliance with the SOP’s, cGMP’s and Quality Standards
- Train, direct and develop hourly employees
- Define and implement new methods of production to improve efficiency
- Set-up, operation, and troubleshooting of manufacturing equipment
- Assist in the development and execution of equipment and process qualification, validation, and protocols, ensure that daily production is running efficiently
- Review’s documentation generated by the Operators
- Experience as: Downstream, Purification: Humalog, Humulin, Drum Thaw, Solubilization/Sulphitolysis & PH Adjustment, Dilution, Chromatography column’s Big Bead Q-sepharose (BBQ), Folding, Tangential filtration (TFF)
Manufacturing Operator: Loestrin, Ferus Fumarate
Warner Chilcott
Fajardo, PR
2010.06 - 2010.07
- Execute manufacturing operations in compliance with the SOP’s, cGMP’s and Quality Standards
- Experience as: Pharma (Solid dosage), Compression Area Operator, Packaging Area Operator, Granulation operator, validation
Manufacturing Operator: Janumet, Levotroxin
Patheon Pharmaceutical
Caguas, PR
2008.05 - 2010.06
- Execute manufacturing operations in compliance with the SOP’s, cGMP’s and Quality Standards
- Experience as: Pharma (Solid dosage), Material Handler Operator, Coating Area Operator, Compression operator, Granulation operator
Education
Master’s degree - Planning & Strategy
NUC University online division
Guaynabo, P.R01.2022
Bachelor’s degree - Software Analysis & Development
NUC University online division
Guaynabo, P.R01.2020
Biotechnology Associate Degree -
Universidad del Turabo
Gurabo, P. R.01.2009
Skills
- People Management
- Management
- Supervisor
- Team lead
- Downstream
- SIP
- CIP
- Sampling swabbing
- Aliquots
- PH meter (calibration and use)
- Conductivity meter (calibration and use)
- UV meter
- OD meter
- Column (manufacturing process)
- Unpack & Packaging process
- PH Adjustment
- Ultrafiltration
- Diafiltration
- Concentration
- Filtration
- Trouble shooting skills
- PT (pressure test)
- Compression
- Blending
- Coating
- Inspection
- Packaging
- QA
- Biotechnology manufacturing process
- Manufacturing process
- Change Over
- Good documentation practices
- CGMP’s
- Train of trainer (Lilly Del Caribe)
- SafeStart
- MES (POMS)
- LIMS
- EBR (Electronic Batch Records)
- Brigade member (AbbVie)
- Heart saver
- CPR
- Batch records review
- CAPA
- Microsoft Office
- MS Word
- Power Point
- Excel
- Batch Analytics
- Delta-V
- Lim’s
- EBR electronic batch records
- TrackWise system
- Reliance system
- SAP
- RPM (RUN PROCESS MONITORING)
- Excellent communication
- Communication
- Team building
- Attention to detail
- Capital projects management
- Capital projects
- Oversee capital projects
References
Furnished upon request.
Languages
Spanish
First Language
English
Proficient
C2
Timeline
Production Supervisor
West Pharmaceuticals
2024.12 - Current
Production Supervisor
Thermo Fisher Scientific
2024.09 - 2024.12
Merck Animal Health
2021.10 - 2024.09
Production Lead (Acting Supervisor)
Jubilant Cadista
2019.06 - 2021.10
Biologic’s Operator ll
AbbVie
2014.11 - 2019.06
Biotech Op.
Eli Lilly.
2011.08 - 2014.11
Manufacturing Operator: Loestrin, Ferus Fumarate
Warner Chilcott
2010.06 - 2010.07
Manufacturing Operator: Janumet, Levotroxin
Patheon Pharmaceutical
2008.05 - 2010.06
Master’s degree - Planning & Strategy
NUC University online division
Bachelor’s degree - Software Analysis & Development
NUC University online division
Biotechnology Associate Degree -
Universidad del Turabo