Michael Cueto Email & Phone Number

Columbus, Ohio, US

San Diego, CA, US

• Spearheaded the design, leadership, and execution of experiments and operations in the development of downstream units for the purification of diverse viral and monoclonal antibody drug products.
• Developed and managed schedules for daily operations, ensuring the success of both Manufacturing and Process Development staff.Client-Based Project Leadership
• Led downstream operations for a range of client-based projects, focusing on refining the downstream processes for client's biologic/vaccine products.Tech Transfer and Scale-Up Expertise
• Orchestrated seamless tech transfer and scale-up processes during client projects, ensured a smooth transition to manufacturing scale operations.
• Ensured GMP qualification of all materials transitioning from R&D scale to manufacturing scale.Mentorship and Training
• Provided hands-on training and mentorship to Manufacturing staff, facilitating the integration of unfamiliar unit operations from R&D to Manufacturing scale.

Alachua, Florida, US

• Leadership and Supervision
• Spearheaded and oversaw the development of manufacturing processes for both upstream and downstream unit operations specializing in the purification of AAV vectors. Proficient in managing diverse platforms such as.
• Design and executed experiments, researching and sourcing reagents, equipment, and materials for the purification of AAV vectors. Proficient in utilizing chromatography and filtration technologies, ensuring scalability.
• Designed, budgeted, and planned for the scaling up of both upstream and downstream processes for insect cell and mammalian cell platforms, specifically for the production of AAV viral vectors. Adhered to cGMP and GLP.
• Authored and/or edited standard operating procedures, ensuring strict adherence to GLP and GDP standards. Forecasted future documentation guidelines to align with FDA regulations.Training and Mentorship
• Trained and mentored new Process Development and Manufacturing staff on upstream/cell growth and downstream/column chromatography/ultra-purification processing. Provided mentorship on cGMP, GDP, and GLP principles.

Philadelphia, Pennsylvania, US

-Supervise and mentor Viral Vector Manufacturing Associates in upstream cell growth and downstream processing including chromatography, tangential flow filtration, and ultra purification to produce various Viral Vectors under cGMP, GLP, and GDP conditions for various Cell and Gene Therapy Clients.-Work closely with Project Management Team and Manufacturing.

Philadelphia, Pennsylvania, US

San Antonio, TX, US

- Leads a team of sterile filling operators to asceptically fill narcotics as potent as Schedule II DEA Classification. Ensure all operators are following proper GMP and GDP. - Frequent work in controlled environments as critical as class 100 enclosures. - Mentor and train operators on new processes as well as assist Engineers in any scale up projects when.

San Antonio, TX, US

- Perform lab experiments and studies to develop commercial regenerative tissue products, while working frequently inside a sterile environment. - Monitor and challenge the overall process and ability of the products while recommending improvements. - Ensure all documentation for each lab experiment is properly filled out while maintaining Good.

Biology

Biology