Timothy Davis
Browns Mills,NJ
Summary
To use my skills and experience in manufacturing to contribute to the production of high-quality products. To work in a fast-paced and dynamic manufacturing environment where I can use my problem-solving skills and attention to detail to ensure that production goals are met. To learn new skills and advance my career in the manufacturing industry. To contribute to the growth and success of a manufacturing company by providing high-quality work and customer service. To work in a team environment where I can share my knowledge and experience to help others succeed.
Overview
22
22
years of professional experience
Work History
Manufacturing Associate III
Catalent
Princeton, NJ
03.2023 - Current
- Perform daily production scheduling activities in conjunction with MFG Supervisor
- Perform and support all manufacturing for both clinical and commercial activities that meet the site’s strategic objectives and is compliant with cGMPs, safety regulations, and FDA standards
- Executes production activities that include cell culturing, aseptic processing, cell counts, expansion, separation, and cryopreservation using appropriate techniques and equipment
- Generate and revise internal documents (SOPs, Batch Records, Forms and Protocols)
- Lead initiations and closures of deviations; serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.Troubleshoot processing and equipment issues
- Work with Facilities and Validation to ensure proper functionality of equipment in conjunction with Manufacturing Supervisor
- Work closely with the Manufacturing Supervisor for current and new manufacturing projects
- Assist with processes/techniques to meet contract objectives in a timely manner
- Lead review and closure of BPRs ensuring completion is performed in a timely manner
- Perform cleaning/disinfection of the manufacturing classified areas as needed per area procedure
- Additional duties as assigned Supervisor.
- Ensure Cleanroom is sterile and fit for use by during daily cleanings of ISO 8 areas along with class A areas, Class B BSC and non-controlled areas as well.
SR. Manufacturing Associate
Celgene/BMS
04.2019 - 03.2023
- Production of blood component lots through cell culture, harvest, and cryopreservation.
- Aseptic technique and operations connections, tubing welding, transfers may be performed in a Biological Safety Cabinet (
- Weighs and measures in-process materials to ensure proper quantities are added/removed.
- Adheres to the production schedule ensuring on-time, internal production logistics.
- Records production data and information in a clear, concise, format according to proper GDPs
- Sop training
- Batch record preparation and review.
- Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
- Motivated, team consciousness individuals are needed to fulfill job requirements
- Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor
- No direct reports will be assigned to this job role.
- Performs other tasks as assigned.
Diagnostic Technician / Equipment
MechanicRoche Molecular Systems
01.2011 - 04.2019
- Monitor Vial Fill Operations – Ensure proper orientation of vials on Fill lines (40,37,29) determine vial cap condition and torque range, check and maintain filllevels
- Requires being alert and having a quick response to machine malfunctions.
Foam Machine Operator
Metl-Span
01.2011 - 09.2011
- Utilized heavy duty Laminator machine to produce varied ranges of size, 6ft thru 32ft insulated foam core deposit metal panels for commercial, industrial and cold storage buildings
- Set-up and run of Laminator and Foaming machines and stations
- Maintain clean and safe working environment.
Direct Base Tissue Technician
MTF Biologics
Edison, NJ
05.2001 - 06.2009
- Trinlun@yahoo.com, MTF/ Musculoskeletal transplant foundation, Quality Assurance - performed environmental monitoring on class 10 clean rooms for viable and nonviable samples, prepared trending reports, captured X-Rays of processed bone grafts for doctor review
- DBX - demineralized human bone matrix through various acid, mixed bone matrix with putty\paste to create a bone filler, filled medical device with bone matrix, prepared final product for shipping
- CAPA Validations
- Base Tissue - setup and processed human bones for transplantable grafts
- Material handler - maintained FIFO order on inventory supplies and stock.
- Skilled at working independently and collaboratively in a team environment.
- Self-motivated, with a strong sense of personal responsibility.
- Proven ability to learn quickly and adapt to new situations.
- Worked well in a team setting, providing support and guidance.
- Managed time efficiently in order to complete all tasks within deadlines.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Excellent communication skills, both verbal and written.
- Passionate about learning and committed to continual improvement.
- Strengthened communication skills through regular interactions with others.
- Paid attention to detail while completing assignments.
- Cultivated interpersonal skills by building positive relationships with others.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
Education
GED -
Prince George
Skills
- QA/QC environmental monitoring
- Class 10,000 clean room environment knowledge
- SOP formulation
- Microsoft Word and Excel
- MSDS Knowledge /QAD
- Aseptic gowning
- OSHA Compliance
- Batch Records
- Maintaining Clean Work Areas
- Manufacturing and Production
- Corrective Actions
- Knowledge of Manufacturing
- Good Manufacturing Practices
- Work Orders
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Each small task of everyday life is part of the total harmony of the universe.
Saint Thérèse de Lisieux
Timeline
Manufacturing Associate III
Catalent
03.2023 - Current
SR. Manufacturing Associate
Celgene/BMS
04.2019 - 03.2023
Diagnostic Technician / Equipment
MechanicRoche Molecular Systems
01.2011 - 04.2019
Foam Machine Operator
Metl-Span
01.2011 - 09.2011
Direct Base Tissue Technician
MTF Biologics
05.2001 - 06.2009
GED -
Prince George
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