Jonathan Rufino Sr.
Germantown,MD
Summary
15+ years experience in manufacturing and biorepository leadership roles for Biotechnology and Pharmaceutical companies, overseeing the assembly of innovative uncoated plate assays. And the inventory, shipments, receiving of various biomaterial collection kits used for clinical trials, and distribution of frozen & refrigerated specimen and vaccines for various assays, in a GLP, GMP or regulated facility, for both commercial and private contracts.
Overview
18
18
years of professional experience
Work History
Manufacturing/Production Manager
Meso Scale Diagnostics
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.
Operation Lead Tech
Thermo Fisher Scientific
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.
Sr. Repository/Kit Production Tech
Fisher BioServices/Thermo Fisher Scientific
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
Timeline
Manufacturing/Production Manager
Meso Scale Diagnostics
01.2020 - Current
Operation Lead Tech
Thermo Fisher Scientific
01.2013 - 01.2020
Sr. Repository/Kit Production Tech
Fisher BioServices/Thermo Fisher Scientific
01.2007 - 01.2013
State of Maryland Life Insurance License Producer
High School Diploma -
Albert Einstein High School