Caridania Martinez

As a cGMP Manufacturing Associate II in DNA Manufacturing at Moderna, I support the production of GMP DNA-based medicines for clinical trials, with a primary focus on DNA Plasmid manufacturing. My responsibilities require strict adherence to cGMP practices, operation of complex manufacturing equipment, accurate documentation, and seamless collaboration with cross-functional teams to ensure operational success.

• Operate and monitor manufacturing equipment in a cGMP environment supporting DNA plasmid production.
• Collaborate with Quality Assurance teams for timely disposition of materials.
• Accurately document batch records, process data, and operational observations.
• Assist with troubleshooting equipment issues and investigating process deviations.
• Follow SOPs, safety guidelines, and gowning procedures to maintain a clean and compliant work area.
• Participate in continuous improvement initiatives to enhance operational efficiency.
• Assisted in process monitoring and ensuring product quality met specifications.
• Operated manufacturing equipment to produce mRNA vaccines efficiently.
• Collaborated with team members to resolve production issues promptly.
• Assisted in training new associates on equipment operation and safety protocols.
• Monitored inventory levels of raw materials and reported shortages to supervisors.
• Clean work areas regularly to maintain a safe working environment.
• Communicated with co-workers to improve unit production.
• Completed day-to-day duties accurately and efficiently.

Job Details: Integra Lifescience is a prospering Tissue Engineering company responsible for production of collagen skin similar to stemcells, to treat patients for severe or mild cases. The product is marketed as multiple brands such as “SurgiMend” collagen matrix for Hernia repair or cancer patients. The collagen undergoes a chemical process and is purified in an ISO 7 cleanroom that is carefully inspected through quality to meet medical requirements.

• Manufacture biologically derived medical devices in a Cleanroom ISO 7 environment. Following time sensitive SOP.
• Provided day-to-day manufacturing floor leadership.
• Provided feedback and supervision of manufacturing team.
• Documented production information via daily system logs and discussed issues with management. Accurately maintaining legible and accurate records, required logs books, records, and other procedures to comply with regulatory requirements using Good Documentation Practice.
• Coordinated with different departments, like logistics, QA, QC to support manufacturing process.
• Collaborated with Operations Manager to ensure labor needs met. Responsible for creating team daily schedule, based on production needs. Making sure Operators are fully trained before they execute the manufacturing process.
• Aseptic Gowning Qualified Trainer for ISO class 7 operations.
• Responsible for the training of all new Manufacturing associates. Directed team building workshops, where all new associates will train with all the equipment they will use inside of cleanroom. Also helping them develop and understand cleanroom behaviors.
• Handles chemicals such as (Sodium Hydroxide, Chloroform,Methanol, Ethanol, PBS (Phosphate Buffate Solution), Isopropyl.. etc).
• Maintained compliance with health, safety and environment practices.
• Examined incoming materials and compared them to documentation for accuracy and quality.
• Perform general cleaning of cleanrooms and other manufacturing spaces.
• Chemical Safety Hood.
• Disinfected and sterilized equipment, equipment, and containers to destroy microorganisms.
• Maintained proper inventory levels for all consumables items inside clean room and gown area. Removed and restock gowns Materials.
• Followed all waste handling guidelines to minimize waste generation.
• Maintained proper inventory levels for all consumables items inside clean room and gown area. Removed and restock gowns Materials.
• Led daily team meetings to prioritize production tasks and address issues.
• Implemented process improvements to enhance production efficiency and quality.

• Assembled products to meet production requirements and daily goals.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Collaborated with team members to meet production deadlines.
• Followed safety protocols and utilized OSHA-approved PPE to foster safe working environment.
• Utilized hand tools and machinery to safely complete assembly processes.
• Loaded and unloaded materials from conveyor belts to support continuous production.
• Operated industrial mixers to compound and blend chemicals.
• Resolved problems, improved operations and provided exceptional service.

• Organized and prepared workstations and materials needed for operations to maximize productivity.
• Assembled products to meet production requirements and daily established quotas.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Collaborated with team members to meet production deadlines.
• Made sure that products were produced on time and are of good quality.
• Design labels and paste them on the packaging materials.