MARIA DATUIN

Manufacturing and Processing Abecma and Breyanzi Cell Therapy for treatment of Multiple Myeloma and Lymphoma

Technical Operations

• Cell isolation and purification to isolate and purify the T cells. Cell culture and expansion by maintaining and manipulating the engineered CAR T cells in controlled bioreactors to promote their growth and multiplication. Transduce viral vector for targeting antigens. Perform aliquots and sterility samples for Quality Control testing to ensure the purity, viability and functionality of the cells before patient infusion. Utilize small hand tools, calibrated instruments, measurement equipment, welders, sealers, micropipette, repeater pipette, scale, LOVO, Multisizers, NC202, Xuri Bioreactors, and Sepax.

Trainer

• Deliver comprehensive training programs such as preparing training modules for trainees, preparing instructional materials, and conducting both theoretical and practical sessions. Evaluate the effectiveness of training by collecting feedback, assessing skill acquisition, and making necessary adjustments to improve training quality. Complete training assignments to ensure the necessary technical skills and knowledge via Success Factors. Attend training sessions and maintain proficiency in cGMP regulations, cell therapy procedures, and safety protocols. Participate in continuous improvement initiatives and process optimization efforts. Train others on SOPs, Work Instructions to successfully complete manufacturing operations. Collaborate effectively with other team members in a fast-paced and demanding environment.

Environmental Monitoring SME

• Perform air sampling using active and passive air samplers. Perform surface swabbing of critical surfaces and analyzing results for compliance with established cleanroom standards and internal protocols. Ensure accuracy and reliability of data collected by calibrating and troubleshooting network efficacy prior to sampling. Documenting and verifying effectiveness of cleaning and disinfection procedures and ensuring proper functionality of cleanroom equipment. Record data, observations, corrective actions, and communication with cross functional teams.

Operated in collaboration with cross functional teams. Responsible for production support of CARVYTKTI Ciltacabtagene Autoleucel, cilta-cel drug product for both clinical and commercial in a sterile cGMP environment.

• Work in collaboration with Operators to engineer Chimeric Antigen Receptor T cell therapy for patients with Multiple Myeloma
• Handle human derived materials, Lentivirus, Apheresis, IL-2, Texmacs and Cell Culture media in a sterile cleanroom facility
• Build process kits according to Batch’s process order
• Issue transactions in SAP to its Purchase Order
• Review batch records for verifications and corrections
• Ensure Lentivirus, Apheresis, and IL-2 transfers from the controlled freezers into the ISO 8 cleanroom in a timely and aseptic manner
• Operate LN2 tanks and verify the Cryopreservation Freezing process with performing all ERP software execution as needed
• Troubleshoot routine and complex issues
• Decontaminate and sanitize all workstations and medical devices
• Enter TSA and contact plates data into eLIMS systems and incubate
• Build strong partnerships with the Warehouse, Engineering, Logistics, Cryopreserve, Micro and Quality teams to work as part of a cross functional team
• Manage material inventory via SAP in collaboration with the warehouse and planning and logistics team
• Perform routine cycle counts of dry and cold materials to maintain accuracy of inventory and expiration of materials daily used for process
• Perform uncontrolled and controlled printing for Batch Records via Tru Vault.
• Maintained overall safe work environment with employee training programs and enforcement of safety procedures.

• Produce Lab In A Test Tube (LIAT) testing kits for Flu, Strep, SARS, and COVID19 viruses
• Collaborated with other departments to optimize production workflows.
• Maintained knowledge of industry policies and procedures to set up and operate equipment safely.
• Assisted with equipment startups and machine installation tasks.
• Performed equipment tests, calibrations and repairs to keep machines running smoothly and prevent malfunctions.
• Optimized production workflows by analyzing processes, identifying inefficiencies, and implementing corrective actions.
• Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
• Set up machines to start production cycles and controlled machine settings.
• Prepared reports and technical documentation of day-to-day production processes.
• Assembled kits according to changing daily work orders and specific customer needs.
• Provided on-the-job training to newly hired workers and team members.
• Inspected products and machines to maintain quality and efficiency.
• Adjusted machines to increase productivity for runs.
• Made sure that products were produced on time and are of good quality.
• Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
• Reviewed production schedules and streamlined processes.
• Assisted in training new operators, sharing knowledge of best practices and promoting a culture of teamwork amongst peers.
• Performed quality checks to identify finish discrepancies.
• Oversaw logistics and inventory management.
• Contributed to cost reduction efforts by monitoring resource usage and minimizing waste during operations.
• Met production targets and tight deadlines by collaborating closely with team members.
• Participated in continuous improvement initiatives, identifying areas for process optimization and recommending changes for implementation.
• Actively participated in cross-functional teams, contributing valuable input on process improvements and best practices for overall operational success.

Manufacture human tissues for reconstructive surgery for breast cancer patients, burn patients, gum replacements, and hernia repair

• Operate in an ISO 7 cleanroom environment with BioSafety Cabinets (Laminar Flow Hoods) applying aseptic techniques as per cGMP guidelines
• Don proper PPE to ensure sanitized environment for both operators and products
• Weighed and measured items to prevent waste and meet quality standards.
• Document human tissue information on batch records, equipment, and cleaning logs
• Inspect and assess raw materials and verify information using Oracle system for electronic batch records as well as paper batch records
• Utilize calibrated scales and orbit shakers to ensure proper amount of tissue and solution volume is in each bottle
• Operate the splitter machine, assemble, and dismantle before and after each batch
• Freeze tissues in controlled freezers following SOP and LOP procedures
• Monitor quality of raw and finished goods before, during, and after production
• Review batch records as per guidelines
• Maintain 5S and ensure inspection and workstations are safe working environment.
• Participated actively in Lean Manufacturing initiatives, driving continuous improvement efforts and contributing to a more efficient production environment.

• Enhanced patient satisfaction by efficiently managing and organizing medical records in a timely manner.
• Streamlined the check-in process for patients, resulting in reduced wait times and increased overall efficiency.
• Increased office productivity by accurately transcribing physician notes and updating electronic health records accordingly.
• Ensured patient privacy by diligently adhering to HIPAA regulations when handling sensitive medical information.
• Provided exceptional customer service to patients, addressing inquiries regarding medical records, appointments, and insurance coverage.
• Developed a comprehensive filing system, enabling easy access to critical documents and efficient retrieval of patient information.
• Contributed to a positive work environment by effectively communicating with team members and offering assistance when needed.
• Reduced clerical errors by carefully proofreading all documentation before submission or distribution within the practice.
• Maintained an organized reception area, creating a welcoming atmosphere for both patients and visitors alike.
• Assisted with scheduling appointments, ensuring adequate time allocation for each patient while minimizing gaps in provider schedules.
• Expedited insurance claims processing by verifying coverage details on behalf of patients before submitting relevant documentation in compliance with payer requirements.
• Handled high call volumes professionally while providing accurate information regarding appointment availability, services offered, and general clinic policies to callers seeking assistance.
• Promoted knowledge sharing among team members by actively participating in staff meetings, sharing best practices, and offering constructive feedback to colleagues.
• Facilitated the smooth transfer of patient information by reviewing incoming medical records for accuracy and completeness before incorporating them into established filing systems.
• Continuously updated personal knowledge of industry developments and trends by attending relevant workshops, conferences, and training sessions as necessary.
• Used computer programs and registration systems to schedule patients for routine and complex procedures.
• Fielded concerns surrounding patients and care, liaising between physician, patient, and insurance company.

• Provided guidance and support to a team of 15-20 Member Services Representatives.
• Provide outstanding customer service and efficiently help members accordingly
• Managed escalated customer concerns, ensuring timely resolution and positive outcomes.
• Member of the Fund-Raising Committee in collaboration with board members and the rotary club members to create events to raise funds for the organization
• Mentored junior staff members, empowering them with the skills needed to excel in their roles as Member Services Representatives.
• Supervise and assess team members by providing constructive feedback and helping develop excellent customer service and promotional skills
• Reconcile financial accounts and make necessary corrections and voids
• Manage clubs, events, and programs using YMCA
• Met with staff for mid-year and annual evaluations software
• Developed and implemented strategies to improve customer service performance, including training programs and quality assurance measures.

Personal Trainer

• Trained clients with organized exercise regimens accordingly
• Assess client’s needs and health restrictions
• Communicated with clients to determine goals and performed client assessments.
• Led, instructed and motivated individuals during cardiovascular exercise, strength training and stretching activities.