Damian Gonzalez

• Aseptic processing in ISO 5 biosafety cabinets, Universal precautions for handling human derived materials in BSL-2 containment areas, Cell expansion using incubators and single use bioreactors, Cell washing processes and automated equipment, Cell separation techniques and automated equipment, OR Cryopreservation processes and equipmentMade sure that products were produced on time and are of good quality.
• Proficient in BMS Business Applications including Syncade/MES/Oracle, EQRMS/Infinity/ Veevo, CellabsAssembled products to meet production requirements and daily established quotas.
• Thorough understanding of media production (if applicable), cell culture, selection/isolation, activation/initiation, transduction, debead (if applicable), expansion, harvest and cryopreservation for CAR-T
• Support deviation investigations and on-time closure of deviations
• Excellent ability to Maintain accurate records perform precise computations if software were to be used
• Ensure batch records for production data and all information are in a clear, concise, format according to proper GDPs.
• Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Collaborated with team members to meet production deadlines.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Cross-trained in other bucket operations
• Used problem-solving and issue-resolution skills to promptly and successfully address production problems.

• Working inside cleanroom wearing PPE from top to bottom for 5-10 hours straight
• Advanced knowledge on product with ability to compound and dispense prescribed medications in accordance with laws and regulations
• Prepares for production run by reviewing production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment
• Responsible to review all documentation including Batch records and Logbooks in “Real Time and Right First Time” and demonstrate error free documentations
• Immediately reports any error or deviations noticed to management
• Filling vials and bottles by operating machines such as (Flex 50, DARA)
• Regulated machine flow, speed, and temperature and stopped and reset machine to address malfunctions
• Advanced knowledge on product with ability to compound and dispense prescribed medications in accordance with laws and regulations
• Conduct routine medication inventories including monitoring for drug expirations and dates and assist with inventory control of medications
• Removed samples for testing by quality assurance personnel
• Reported malfunctions and errors to supervising staff, addressed concerns and supported other machine operators completing challenging workloads under tight schedules
• QC experience and able to inspect, find errors, and identify the necessary factors needed in order to be able to send out product
• Gained knowledge on proper clean room gowning
• Able to multi-task, motivated and interested in advancing to higher positions in the pharmaceutical field
• Clean room experience – solid knowledge of functional operations within the work area (batch review, product quality, production procedures)
• Able to use specified tools in order to make precise measurements and document them properly according to GDP (good documentation practice)

• Counted and recorded finished and rejected packaged items
• Observed machine operations to verify quality and conformity of packaged products, stepping in to resolve issues promptly and avoid costly production errors
• Resolved problems, improved operations and provided exceptional service
• Decontaminated surgical instruments to remove bacteria and other contaminants before sterilization.
• Completed minor preventative maintenance and mechanical repairs on equipment
• Completed all paperwork, recognizing any discrepancies and addressing them in timely fashion
• Aseptic Gowning Qualified
• Good Manufacturing Practices
• Suggested and implemented new ideas to improve quality, reduce cost and support production work environment
• Dealt with human tissue and was responsible for taking measurements of thickness and cutting specified sizes using machinery
• Ability to detect defects on tissue (inspect what can be used and not)
• Documented all work through batch record and software
• Conducted testing procedures during manufacturing process to ensure quality on product
• Learned how to work through operations in a team effort aspect
• Able to perform independently when working as well as flexibility in shifts
• Clean room experience – solid knowledge of functional operations within the work area
• Mastered performing operations which involve using precise measurements and machinery (autoclave)
• Gained the foundation of using software computations and ability to record necessary information on batches
• Calibrated machines to maintain required productivity levels and adherence to quality standards
• Made sure that products were produced on time and are of good quality.

Some college

• Honor Roll [Semester and Year]

Currently enrolled part-time