• 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.• Mentored incoming PD lab support personnel on downstream units of operations and associated equipment, contributing to a knowledgeable and proficient team.

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 insect cell, baculovirus, and mammalian cell transfection-based manufacturing.Experimental Design and Execution• 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 across insect cell and mammalian cell expression systems.Scaling and Budgeting• 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 guidelines, ensuring compliance throughout the scaling process.Documentation and Compliance• 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.

-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 Clients in the efforts to complete each Client's Viral Vector Manufacturing needs.

- 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 R&D works with our manufacturing team. - Assists Supervision and Management with proper scheduling of daily tasks and manufacturing activities.- Started as an Operator Sept 2013 - Became Group Lead Sept 2014.

- 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 Documentation Practice. - Ensure all lab equipment is functioning efficiently and properly. - Clean entire lab area as necessary and ensure cleanliness complies with FDA and Quality Control Guidelines. - Work closely with, Supervisor, and Project Managers to ensure all required activities were carried out for each experiment and study.