Gabriel Ramirez
Willingboro,NJ
Summary
Manufacturing professional with strong background in overseeing and optimizing production processes. Adept at fostering team collaboration and driving results through effective leadership and problem-solving. Skilled in workflow management, quality control, and meeting production targets while adapting to changing operational needs. Known for reliability and results-driven approach.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Clinical Manufacturing Supervisor
Matinas BioPharma
08.2020 - 10.2024
- Identified problems and implemented effective solutions.
- Maintained proper inventory levels.
- Completed production plans by scheduling and assigning personnel to daily tasks.
- Communicated job expectations and monitored employees.
- Collaborated with cross-functional teams to achieve production goals and optimize workflow.
- Reduced downtime by conducting regular equipment maintenance and addressing issues promptly.
- Participated in departmental meetings to share insights from the manufacturing floor, contributing valuable input towards decisionmaking.
- Performed accident investigations.
- Conducted performance evaluations, identifying areas for individual improvement.
- Reviewed documentation such as invoices and shipping paperwork for accuracy and compliance.
Clinical Manufacturing Lead Operator
Matinas BioPharma
01.2017 - 08.2020
- Develop, write and implement work instructions for SOP’s and BMR
- Perform regular cycle counts on inventory an investigate any discrepancies
- Collaborate with various document owners, authors and technical resources to collect required draft content of document to enable subsequent processing, review and approval process
- Review documents including master batch records, protocols and reports
- Contact and work with suppliers to place orders an obtain proper documentation
- Receive, inspect, verify and collect sample of all incoming raw material
- Perform manufacturing of clinical trials and contribute to the development of clinical operations
- Perform I/Q and O/Q for new production equipment’s use in the cGMP and Lab areas
- Knowledge in operation of the Reactor Kettle vessels, Homogenizer, Centrifuge, Tangential Flow Filtration, Mobile Minor Spray Dryer
- Trained new team members on equipment operation, safety protocols, and company policies, fostering a skilled workforce.
- Fostered a positive work environment, promoting open communication among team members to address concerns or suggestions for improvement.
- Assigned tasks to team members based upon individual strengths and experience, realizing productivity and workflow improvements.
Lead Production Technician
Lupin Somerset
01.2015 - 01.2017
- Operation of Wurster column, top and bottom spray
- Process of the spray dry coating using vector fluid bed dryer, blending, granulation, milling, suspension operations
- Changed equipment over to new product
- Clean and or disassemble equipment after the completion of process run as per SOP
- Setup and startup of equipment to run and obtain all parameter specifications as per batch record
- Auditing – prepare documentation for auditor examination, coordinating resources, respond to audit findings
- Development/refinement of QMS documents – participate in writing standard operating procedures (SOP’s), working practices, process improvement, etc
- Provide standard operating procedure training
- Enter date for various quality systems into their respective software application
- Collaborate with various document owners, authors and technical resources to collect required draft content of document to enable subsequent processing, review and approval process
- Review documents including master batch records, protocols and reports
Lead Production Technician
Tris Pharma
01.2011 - 01.2015
- Use of fluid bed dryer, Fitz mill, mechanical sifter, high shear mixer, encapsulation machine
- Spray dry coating, blending, granulation, milling, encapsulation and suspension processes
- Changed equipment over to new product
- Clean and/or disassemble equipment after the completion of process run as per SOP
- Setup and startup of equipment to run and sustain all parameter specifications as per batch record
- Adjusted machine feed and speed if malfunctioned or not meets specs
- Visually inspected filled material to ensure normal and safe operation
- Take and record measurements and weights of capsules/tablets throughout the run
- Trained in the manufacture and security of DEA Schedule I, II and III controlled drug substances
- Responsible for training new hires to operate the fluid bed dryer
- Responsible for accountability of controlled substances during product processing
- Helped achieve company goals by supporting production workers
- Responsible for setting minimum standards and providing technical guidance and support to operators
- Actively suggested operational improvements to enhance quality, improve production times and reduce costs
Production Technician
Aurolife (Aurobindo Pharma USA)
01.2009 - 01.2011
- Maintain and calibrate all equipment needed during production on a daily basis performing granulation and drying operations using high shear mixers and Fluid Bed Dryers following written instructions per the batch record
- Monitored and adjusted production processes or equipment for quality and productivity
- Knowledge on the Mechanical sifters, Fitz mill and V-blenders for the screening milling and blending process as per batch record
- Follow written instructions per SOP and cGMP to perform major and minor cleaning on all equipment and or room while following Lock out/Tag out procedures
- Follow gowning procedures by wearing uniform, steel toe shoes, shoe cover, head cap, sleeves, latex gloves, safety glasses, respirators with filter
Production Technician
Ohm Laboratories
01.2007 - 01.2009
- Knowledge of cGMP, OSHA, FDA and DEA regulations Accountable for adhering to the cGMPs and operation of manufacturing equipment
- Performed blending, screening and milling operations using V blenders, Russel sifters, Quadro mills etc
- Performed tablet printing, granulation and drying operations using High shear mixer, Fluid Bed Dryers and Tablet printing machine
- Follow written instructions per the Batch Record and Operating Procedures of the equipment
- Document all the procedural operations in the Batch Record
- Follow gowning procedures by wearing uniform, steel toe shoes, shoe cover, head cap, sleeves, latex gloves, safety glasses, respirator with filter
Warehouse Operator
Church and Dwight
01.2006 - 01.2007
- Shipping & Receiving
- Unloaded, picked, staged and loaded products for shipping
- Operation using RF scanners
- Received incoming shipments and reviewed contents against purchase order for accuracy
- Operated powered lift trucks, floor sweepers, pallet jacks and forklifts safely, with a 0% incident rate
- Used propane forklift to load trailer at warehouse
- Loaded flat bed by forklift and hand truck
Education
High School Diploma -
Learning Center of Roosevelt
Skills
- Critical Thinking
- Complex Problem Solving
- CPR/AED Certified
- Time Management
- Forklift Operation
- Operation and Control Management
- Trouble Shooting
- Inventory Control
- Excellent Written and Verbal Communication
- Good Documentation Practices
- Lean manufacturing principles
- Technical knowledge
- Process Improvement
- Safety audits
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Supervised team of 15 staff members.
- Trained New and current Manufacturing Operators.
- Contributed to productivity with new improvements.
- Collaborated with team of 25 in the development of LNC
Certification
- CPR/AED Certification
Languages
Spanish
Native or Bilingual
Timeline
Clinical Manufacturing Supervisor
Matinas BioPharma
08.2020 - 10.2024
Clinical Manufacturing Lead Operator
Matinas BioPharma
01.2017 - 08.2020
Lead Production Technician
Lupin Somerset
01.2015 - 01.2017
Lead Production Technician
Tris Pharma
01.2011 - 01.2015
Production Technician
Aurolife (Aurobindo Pharma USA)
01.2009 - 01.2011
Production Technician
Ohm Laboratories
01.2007 - 01.2009
Warehouse Operator
Church and Dwight
01.2006 - 01.2007
High School Diploma -
Learning Center of Roosevelt
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