Travis Arola Email & Phone Number

Gainesville, Florida, Us

Gainesville, Florida, Us

Mclean, Virginia, Us

Rockville, Md, Us

Rockville, Md, Us

San Diego, Ca, Us

- Managed DoD- and NIH-funded vaccine, mAb, and CapEx projects totaling over $200M, ensuring goal definition, resource allocation, and project outcome- Restored client confidence by assuming project management responsibilities of DoD CapEx projects to double the manufacturing capacity to over 180M doses/year- Led successful completion of BARDA and JPEO-CBRND partnership with Ology Bioservices to expand domestic fill-finish capacity for COVID-19 countermeasures under Operation Warp Speed, validating automated equipment and process to fill at least 5,000 vials/day- Fostered positive working relationships with teams, clients, and leadership counterparts- Tracked cost, schedule, and performance, preparing and developing project-specific policies and procedures

Alachua, Florida, Us

- Utilized lean six sigma tools to identify and resolve bottlenecks, reducing new project risk assessment cycle time for a Biosafety Level 3 (BSL-3) facility from 1 month to 1 weeks- Created and implemented a Department of Defense FAR-compliant site risk management program, unlocking access to over $500M in contracts- Executed risk management for U.S. Government projects, ensuring compliance and timely delivery

Alachua, Florida, Us

Responsible for cGMP document control program and staff

Alachua, Florida, Us

Led transition from paper to validated electronic Quality Management Systems for a pharmaceutical plant, using ISPE GAMP-5 risk-based approach

Gainesville, Fl, Us

- Spearheaded regulatory policy and compliance for Biologics and Spine product lines- Provided regulatory strategy leadership to Engineering & Development- Responsible for approval of marketing literature, SOPs, labeling, and drawings- Managed domestic and international registrations, approvals, and 510(k) clearances

- Influenced FDA regulatory guidance development for new medical device classification, resulting in increased market share for a key product in a commodity market- 31 510(k)s, 2 IDEs, multiple pre-IDEs and pre-Subs, 4 Canadian Class IV approvals, 2 Australian Class III approvals, multiple Class I, IIa, IIb and III CE Mark devices- Managed medical device and human tissue regulatory submissions- Negotiated with FDA in pre-Sub and on-site meetings- Managed relationships with regulatory counterparts in distributors- Led regulatory strategy for new product development teams- Authored or managed all domestic (510(k), pre-IDE, pre-Sub, IDE, 522 study) and international submissions- Responsible for regulatory compliance of labeling and marketing materials- Conducted impact assessments and prepared comments on developing FDA and international regulations and standards- Managed clinical literature research, analysis and writing- Developed regulatory strategies balancing market strategy, manufacturing capabilities, regulatory compliance risk, and corporate objectives- Determined the impact of proposed manufacturing changes on existing regulatory approvals and licenses

Gainesville, Florida, Us

Researcher for Drs. Christopher Batich, Chayi Shen, and Kevin Powers.- Encapsulated drugs in microspheres for controlled release.- Synthesized hydrogels for coatings and in bulk.- Utilized pH-swelling polymer in microspheres and surface modification

Miami Lakes, Fl, Us

- Prototype generation- Animal studies

- Prototype development- R&D

Master Of Science (Ms), Materials Science And Engineering

Bachelor Of Science (Bs), Mechanical Engineering