Jonathan Rufino Sr.
Germantown,MD
Summary
Experienced Manufacturing/Production Manager with over 15 years in the biotechnology and pharmaceutical industries, specializing in leading teams to optimize production processes and ensure compliance with GLP, GMP, and other regulatory standards. Demonstrated success in overseeing the assembly and distribution of critical medical supplies, including uncoated plate assays and vaccines. Skilled in driving continuous improvement initiatives to enhance efficiency, compliance, and team performance.
Overview
18
18
years of professional experience
Work History
Manufacturing/Production Manager
Meso Scale Diagnostics
Rockville, MD
01.2020 - Current
- Responsible for overseeing and increasing all manufacturing production and leading the continuous improvement process through training, development and safety of employees
- Involves staffing, performance appraisals, training, and developing subordinates, ensuring operational goals are met.
- Coordinated the maintenance of equipment, tools, and facilities to maximize efficiency.
- Trained new personnel on the safe operation of machinery and production processes.
- Enforced company policies, procedures, rules, and regulations among production staff.
- Resolved employee issues or grievances related to safety, productivity, or morale issues.
- Evaluated performance of employees on a regular basis to identify areas for improvement.
- Created weekly work schedules to meet customer demands while optimizing labor costs.
- Analyzed production data to develop strategies for improving efficiency and reducing waste.
- Reviewed individual employee performance to correct issues and enhance productivity.
- Coordinated production requirements with material handling and staffing functions.
- Supported safe and clean work environment by educating and directing personnel on use of control points, equipment and resources.
- Monitored staff training and output to meet compliance, productivity and revenue goals.
- Recommended and implemented measures to improve production methods and quality of products.
- Established and updated production schedules to meet changing demands.
- Supported safety programs to reduce and eliminate employee injuries.
Operation Lead Tech
Thermo Fisher Scientific
Rockville, MD
01.2013 - 01.2020
- Managed the life cycle of commercial and the government projects, overseeing the inventory, shipment, and receiving of vaccines, biospecime using ERP databases, facilitating client relations, and ensuring compliance with FDA and cGMP requirements
- Responsible for contract renewals and maintaining client-specific databases.
Repository/Kit Production Tech III
Fisher BioServices/Thermo Fisher Scientific
Rockville, MD
01.2007 - 01.2013
- Managed high-volume biological specimen repository operations, facilitated client visits and government inspections, and oversaw inventory and distribution
- Provided training and ensured compliance with federal and state regulations.
Education
State of Maryland Life Insurance License Producer
09.2024
High School Diploma -
Albert Einstein High School
06.2003
Skills
- My approach to analyzing and improving processes
- Strong knowledge of manufacturing processes, including lean manufacturing principles and methodologies
- Excellent leadership and communication skills, with the ability to inspire and motivate teams
- Proven ability to drive continuous improvement initiatives and achieve results
- Experience working in a regulated manufacturing environment (eg, FDA, ISO)
- Strong analytical and problem-solving skills
- Proficiency in manufacturing software and ERP systems
- Experience of biological GMP manufacturing operations in particular plate Assay assembly in a Clean Room, handling and Freezing processes
- Promote Practical Process Improvement (PPI) to achieve cost savings goals and safety
- Strong technical knowledge of manufacturing processes, quality systems, and regulatory requirements (eg, USDA, ISO, FDA,)
- Ability to work optimally in a cross-functional team environment
- Attention to detail and commitment to accuracy
- Experience in a regulated industry such as pharmaceuticals, healthcare, or manufacturing
- Proven ability to work in a fast-paced environment across multiple functions
- Experience writing and investigating quality records
- Strong knowledge of cGMPs
- Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply
- Proven experience in document and label control management
- Proficiency in electronic document management systems and software
- Strong understanding of regulatory requirements and industry standards
- Excellent organizational and interpersonal skills
- My approach to analyzing and improving processes
- Organizational Skills
- Problem Solving Abilities
- Analytical Skills
- Time Management
- Decision-Making Abilities
- Communication Skills
- Oversee and coach employees
- Ensure the safe environment
- Lean Manufacturing
- Upstream production processes under GMP compliance
- DOT/IATA and HAZMAT regulation knowledge
- In-Trak, Nautilus, Oracle, and TrackWise
- In-depth knowledge of GxP operations as it relates to the FDA’s CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
- OSHA
- Forklift driving certification
- SharePoint
- Champion Safety and 5S
Qualificationhighlights
- PPI (Practical Process Improvement Business System)
- In-depth knowledge of GxP operations as it relates to the FDA’s CFR 21 Part 11 requirements and well as Good
- GLP & cGMP
- GDP
- ISO
- Ample Logistical experience
- 2D & 3D Label Design Printing
- Familiar with FDA Guidelines
- Sharedpoint
- In-Trak, Nautilus, Oracle, and TrackWise
- DOT/IATA and HAZMAT
Languages
- English
- Spanish
References
References available upon request.
Timeline
Manufacturing/Production Manager
Meso Scale Diagnostics
01.2020 - Current
Operation Lead Tech
Thermo Fisher Scientific
01.2013 - 01.2020
Repository/Kit Production Tech III
Fisher BioServices/Thermo Fisher Scientific
01.2007 - 01.2013
State of Maryland Life Insurance License Producer
High School Diploma -
Albert Einstein High School
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