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

Lynne Cooper

ISPE Chesapeake Bay Area Chapter

The role of the Affiliate/Chapter Board of Directors is to manage the operations of the local Affiliate or Chapter in a cost-efficient manner, consistent with the standards and branding of the Society, providing programs of particular interest to Members in the local area. 

Responsibilities to HQ 
Follow up on and complete any unresolved issues from your predecessor Maintain individual ISPE membership and remind Board and Committee Members to do the same Serve on the North American/South American Affiliate and attend all meetings Maintain ongoing communication with and serve as liaison with Affiliate/Chapter Relations team in your region. Comply with ISPE’s policies and procedures as noted in the Chapter Charter. Send required Chapter reports to ISPE’s Affiliate/Chapter Relations regional team when due Assure that all documents, certificates and reports have been filed as required by local, state, federal and country laws.

Responsibilities to Affiliate or Chapter 
Be an elected and voting member of the Affiliate/Chapter Board of Directors 
Attend and preside over all Affiliate/Chapter Board and general membership meetings and functions 
Provide consistent strategic guidance for the Affiliate/Chapter Understand roles and responsibilities of officers, directors and volunteers; motivate and mentor officers, directors and volunteers and 
Set clear expectations Coordinate overall Affiliate/Chapter planning and activities Appoint the Chairs of all Affiliate/Chapter committees.
Assure that all documents, certificates and reports have been filed as required by local, state, federal or national laws Act as a signer of contracts, agreements, check and drafts.
Serve on the committee responsible for hiring an Affiliate/Chapter Manager Build future leadership – identify new leaders and effectively incorporate new board members into the group.

President 

El Sea

Advocate for Owners in developing strategy as well as executing needed activities successfully with clear knowledge of what goes on in pharma manufacturing (cGLP, cGMP). Training for the non scientist in the communication of a successful projects.

Principal 

Critical Systems, Inc.

As Director of the already awesome team at CSI we'll bring copper welding to the market in a huge way!  Helping welders be more safe, efficient, productive with minimal (to no) leaks with copper welding. CSI provides a wide array of services, these new copper welding

Special Projects Manager

WeldChain LLC

Supporting development of a revolutionary green quality management tool, for orbital welding in the industrial and pharmaceutical space. Paper documents can be a thing of the past! 

Single source of truth! 

Immutable data! 

Process piping gets a step forward along with our goal toward more global sustainability. 

There are rewards for the tradespeople! Supporting the trades!

Win. Win. Win.

Co-Founder & Chief Operating Officer 

ISPE

"Women in Pharma® is a safe place where you can share your dreams and challenges and have a place to be celebrated." Jennifer Lauria Clark, USA, CAI

Women in Pharma® provides women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics. In collaboration with a global network of esteemed pharmaceutical professionals, we provide brilliant women across the globe the tools they need to tackle the status quo and move their careers forward with confidence and overwhelming support.

Woman in Pharma® Ambassador's are:
Encouraging:
Career development
Education
Mentorship

Helping:
Change lives
Further diversify the industry on a global level
Grow a global network of women who are learning from and inspiring each other

Expanding:
Your way of thinking through cultural discussions and industry insights
Your professional network through virtual and in-person networking opportunities
Your platform to share what you’ve learned throughout your professional experiences

ISPE National Women in Pharma Brand Ambassador Committee

ISPE Board Member - Cheasapeake Bay Chapter

Public Speaking  

Lab Design 2022 - Speaker - "Adaptability and Flexibility" 
I2SL Conference Panelist 2021 – “Green Chemistry and Community Awareness” 
PDA - Parenteral Drug Association - "4th Annual Leaders in Life Sciences: Advancing Insights from Leading Women in Life Science"
I2SL Webinar Moderator, April 18, 2021 – “My Green Lab and Beyond Benign – Green Chemistry”
Washington Building Congress Panelist, November 5, 2020 – “Current state of Life science and Healthcare Market”
I2SL Conference, 2019 Presenter – “Collaborating in the same language for team success”
Lab Design Conference, 2018 Presenter - “Creating Efficiencies in Projects with the Team”

National Public Speaker

Facility Logix  LLC

Principal / Owner

Leading a team of focused managers within the organization and growing while ensuring quality and consistency in the customer experience is my added focus in charge of the Project Management Team at Facility Logix. We have created and implemented proven processes and procedures to enable complex documentation is complete as well as products and services delivered meet and exceed expectations. Leading team members to always think several steps ahead with the end in mind and a continued focus on the end result. We are growing and refining our trusted network of team collaborators. We are focused on keeping at the forefront of trends in this quickly changing marketplace of both biotechnology, regulatory and construction. We keep an eye on how we can constantly improving and adapting to better provide complete services to our clients.

Director of Project Management Service

Facility Logix

I specialize in providing top quality project management for life science and bio-pharmaceutical facilities.  We focus on providing a level of service that provides our clients with peace of mind and comfort in knowing the team experience and commitment we demonstrate is second to none.  

We are by our clients side as a partner and team member every step of the way.  Our multi-disciplinary approach allows us to model what we have learned establishing incubators, accelerators, and life-science and bio-pharmaceutical facilities to the establishment of other innovation and technology-based business facilities.

Some of our clients include commercial real estate firms and developers, biotechnology companies, public and private institutions, and economic development organizations.

We bring the skills, expertise, and experience required to meet our client’s needs.  We understand that you demand a facility capable of exemplary performance.  At Facility Logix, we build performance.

Senior Project Manager

Edgley Construction Group

Edgley Construction Group, Inc. is a full service design/build team who's services include pre-construction planning, space planning, engineering, construction management, general contracting, and permitting.

Weinstein Properties

Assistant Project Manager Mulitfamily Housing Renovations

Assistant Project Manager - Capital Improvements

Leveraging over two decades of expertise in construction and project management, I excel in steering complex projects to fruition across life sciences, industry, and pharma sectors. My proficiency is certified with an OSHA 30HR credential, complemented by my adeptness in analytical thinking, fostering teamwork, and leading virtual collaborations. 

As the co-founder and COO of WeldChain LLC, I pioneer eco-friendly quality management solutions in orbital welding through innovative blockchain applications, ensuring reliability and efficiency. Then founding El Sea LLC, a Project Management Execution Support service dedicated to the life sciences and furthering the biopharmaceutical market sectors. My commitment extends to championing women’s roles in pharma and trades, epitomized by my leadership roles with ISPE and my founding of El Sea. I am driven by a conviction that collaboration, innovation, and sustainability are the cornerstones of progress in my profession. 

Now working as well with more companies to bring even more innovative technology strategies to bridge the gap in the trades to execute these highly technical projects and get products to patients! We can create SAFER work environments for the trades to work in and SAFER for patients to receive care with those same skilled trades. We all breathe medical grade air eventually in our lives, let’s keep it the high quality we all depend on! Critical Systems Inc. supports welders, being the best they can be with easy to run and well maintained equipment! Not only CAN we innovate, we put it to ACTION, we DO!

taplio

The Battle

Thomas O'Donnell

Lynne Cooper

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