Travis Arola Email and Phone Number
Travis Arola work email
- Valid
- Valid
- Valid
- Valid
Travis Arola personal email
- Valid
I am currently supporting the mission of MLM Biologics in a RA/QA capacity. The Team at MLM Biologics offers an advanced collagen-based, medical-economic solution for wound closure. bio-ConneKt® Wound Matrix is a progressive wound treatment option indicated for healing a wide range of wounds. As a Project Manager II at Resilience, I applied over two decades of experience and skills in biologics, medical device, and tissue regulatory, quality and risk management to manage a portfolio of US government and commercial projects totaling over $200 million. I worked with a team of experts in advanced manufacturing and development of complex biologics and vaccines, and ensuring the delivery of safe and effective products to the market.I am motivated by the mission of advancing the science and technology of medical devices, biologics and vaccines, and I value innovation, quality, and collaboration. I am skilled in communication, pharmaceuticals, and strategic thinking, as well as project and portfolio management, document control, quality management systems, and risk management programs. I have a master's degree in materials science and engineering from the University of Florida and a bachelor's degree in mechanical engineering from Ohio University.
-
Director Ra/QaMlm Biologics, Inc. Oct 2024 - PresentGainesville, Florida, Us
-
Ra/Qa ConsultantMlm Biologics, Inc. Mar 2024 - Oct 2024Gainesville, Florida, Us
-
Certified Tissue Bank Specialist (Ctbs)American Association Of Tissue Banks 2007 - PresentMclean, Virginia, Us -
Regulatory Affairs Certification (Rac), E.U.Regulatory Affairs Professionals Society (Raps) 2005 - PresentRockville, Md, Us -
Regulatory Affairs Certification (Rac), U.S.Regulatory Affairs Professionals Society (Raps) 2002 - PresentRockville, Md, Us
-
Project Manager IiResilience Jan 2019 - Dec 2023San 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 -
Risk ManagerOlogy Bioservices, Inc. Jan 2017 - Dec 2018Alachua, 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 -
Documentation & Cmc Support ManagerOlogy Bioservices, Inc. Jan 2015 - Dec 2016Alachua, Florida, UsResponsible for cGMP document control program and staff
-
Quality Systems ManagerOlogy Bioservices, Inc. Jul 2013 - Dec 2014Alachua, Florida, UsLed transition from paper to validated electronic Quality Management Systems for a pharmaceutical plant, using ISPE GAMP-5 risk-based approach
-
Director Regulatory BiospineExactech Jan 2013 - Apr 2013Gainesville, 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 -
Regulatory Affairs ManagerRti Biologics, Inc. 2000 - 2012- 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
-
ResearcherUniversity Of Florida 1995 - 2000Gainesville, Florida, UsResearcher 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 -
Co-Op StudentCordis 1995 - 1996Miami Lakes, Fl, Us- Prototype generation- Animal studies -
Co-Op StudentEthicon Endo-Surgery 1992 - 1993- Prototype development- R&D
Travis Arola Skills
Travis Arola Education Details
-
University Of FloridaMaterials Science And Engineering -
Ohio UniversityMechanical Engineering
Frequently Asked Questions about Travis Arola
What company does Travis Arola work for?
Travis Arola works for Mlm Biologics, Inc.
What is Travis Arola's role at the current company?
Travis Arola's current role is RA/QA Consultant at MLM Biologics | RAC, CTBS, MS in Materials.
What is Travis Arola's email address?
Travis Arola's email address is tr****@****hoo.com
What schools did Travis Arola attend?
Travis Arola attended University Of Florida, Ohio University.
What skills is Travis Arola known for?
Travis Arola has skills like Design Control, Iso 13485, Fda, Medical Devices, Regulatory Affairs, Quality System, Biomedical Engineering, Research, Biologics, Biomaterials, Product Development, Commercialization.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial