Rees Scientific

VP of Quality and Validation

Lifecycle Labs

Environmental Monitoring (EM) services for GMP clean rooms.

Investor

Crazy Ventures

Kolbe Certified / Business Coach / Investor 

I started my entrepreneurial journey in 2007 with my brother. Together we grew our company from 2 to 250 people in just a few short years. Making the Inc 5000 list 5 years in a row.

Tommy was able to get out of the day to day of his business and focus on his passion to help entrepreneurs achieve freedom in their own lives.

Chief Adventure Officer | Business Coach | Investor

Washburn Air

Genesis AEC

CQV Services

Azzur

At Azzur, it’s not just about growing in size – it’s about evolving into something much bigger than the sum of our united companies. Our holding company model allows businesses to take advantage of internal services such as marketing, payroll, accounting and HR while staying autonomous.  In addition, Azzur provides advisory, consulting and interim management in the areas of financing, business strategy, sales and marketing, customer acquisition, business development, and capital acquisition. This model permits business owners to participate in the success of other companies by having shared equity in the holding company.  At Azzur, we have proven this type of collaboration drives development, fosters innovation and equates to outsized growth.

Co-Founder

Discovery to delivery. These three words say a lot about what we do.  At Azzur Group, we’ve grown our business around the needs of clients by providing seamless service through every stage of the product lifecycle. Named one of the Inc. 5000 Fastest Growing Companies in America by Inc. magazine, Azzur Group serves the pharmaceutical, biotechnology and medical device industries by offering a variety of consulting services and project resources within the quality assurance, laboratory, clinical trials, IT/IM, business processes, manufacturing, operations, and research and development settings.

Sanofi Pasteur

Consultant

Validation Consultant

GlaxoSmithKline Biologicals

Hi, I'm Thomas O'Donnell, an entrepreneur and business owner with 20+ years of experience in the Pharmaceutical and Biotech industries. My Kolbe MO is 4-4-6-7, and my top five Strengths Finder attributes are Simplifier, Includer, Relator, Futuristic, and Belief, supported by Self-assurance 🌟.

As a dedicated leader in the Healthcare and Life Sciences industry 🌐, I've honed my skills in building start-ups, project management, facilitation, coordination, and team-building, supporting professionals in highly-regulated fields like Pharmaceutical and Biotech.

My unique ability lies in connecting with individuals, understanding their passions, and helping life science service companies grow through collaboration and strategic thinking 💡. I create collaborative environments, fostering open dialogue, knowledge sharing, and innovation, driving success in commissioning, qualification, and validation processes.

I believe that most growth results from taking many small steps 🚶‍♂️🚶‍♀️. Success in pharma, biotech, labs, or validation projects 🧪🔬 often stems from consistent small steps forward. I'm passionate about helping professionals learn about commissioning, qualification, validation, implementing EOS Worldwide, and business development 🚀.

Throughout my career, I've collaborated with renowned clients and stakeholders, effectively coordinating activities for seamless execution of commissioning, qualification, and validation processes, maintaining the highest standards of regulatory compliance.

As a seasoned professional in the Pharmaceutical and Biotech sectors, I'm eager to connect with like-minded professionals and share insights that drive progress in these dynamic fields 🔗. Feel free to reach out to discuss potential opportunities, exchange knowledge, or explore how we can work together to advance the industry and achieve success 🌟.

I enjoy discussing #CQV, #Validation, #Qualification, #ISPE, #entrepreneurship, #eosworldwide, and #startingabusiness.

Keywords: Pharmaceutical, Biotech, Validation, Commissioning, Qualification, EOS Worldwide, Regulatory Compliance, Project Management

Thomas O'Donnell

Endo International plc

Associate Director Program Management

SSi People

Responsible for the development and  implementation of the Cell Therapy Development (CTD) strategy initiatives for US-site operations , Bristol Myers Squibb. Current responsibilities include the development of IT solutions for proficient capital expenditure tracking and the harmonization of resource initiatives.  In addition, I have successfully supported the Portfolio Strategy and Integration (PSI) team by leading product development activities for CMC and biologic portfolio opportunities.

Senior Manager Strategy Business Operations

Novartis

Responsible for the management of the quality components associated with commercial readiness programs including suitability assessments of third party suppliers and product launch readiness. Point lead for combination product remediation program for Novartis/Sandoz portfolios.

Associate Director, External Supply Operations-Quality

Sandoz

Senior manager responsible for early phase development activities for complex injectable generic product portfolio.  Internal evaluation point lead for development partner oversight and contract management. Team lead for development activities up through filing including regulatory response management and commercial readiness.

Development Project Manager, US Pipeline and Launch Management

Strategic thinker experienced in the program management of development and commercial manufacturing initiatives. My experience spans across generic, brand and medical device applications. I take pride in driving towards a customer focus through stakeholder alignment and team collaboration on product life-cycle initiatives.  My management expertise includes business operations, program/ portfolio management , third party engagement, regulatory support, supply and quality management.

taplio

The Battle

Thomas O'Donnell

Michael Manley

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