An Owner’s Guide to Building Life Sciences Facilities

An Owner’s Guide to Building Life Sciences Facilities


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Know Where to Start for GMP Manufacturing, Research Greenhouse, and Lab Construction Projects

Designing and constructing life sciences capital investment projects comes with a lot of risk. It is critical to set the right expectations from the start with budget, timeline, and user requirements so your lab construction (or other life science project) is set up for success. For project owners building complicated projects for the first time, building a first-of-its-kind facility, or breaking ground in an unfamiliar area, the task can seem daunting.

That’s why we are sharing insights on where project owners should start and what works well when planning on building or renovating a laboratory, GMP manufacturing facility, advanced research greenhouse, or similar highly regulated life sciences facilities.

How to Kick Off Life Sciences Construction Projects

From initial idea to operational readiness, a major life science project can easily become a behemoth in scope, budget, and schedule. The thousands of moving parts involved in such an endeavor require diligent oversight from the outset. But how do you get started? In short, your first step should be to contact an experienced construction program manager.

Program managers who specialize in life sciences will always begin with the end in mind and are knowledgeable in every aspect of complex projects. They ask the right questions up front while bringing attention to common pitfalls that can cause cost overruns and schedule delays. Program management consulting firms work with project owners at the concept and design stages of a project lifecycle and can rapidly develop solutions for common challenges since they have likely “been there and done that” in many cases.

A good program manager is approach-agnostic and will help you determine the right type of delivery method to suit your needs. They will also vet the pros and cons of various locations, teaming partners, and alternative solutions. Program managers also can assist with defining user requirements and scope development so that you are not over or under designing for your unique project’s needs.

One of the best ways to ensure consistent project success is to work with a life sciences consulting firm that offers a variety of partnership models and services to suit your needs.

Competing Priorities and Limited Resources?

New or busy project owners seeking the most efficient process to build a life science facility such as a BSL 2 lab, for instance, may want to consider seeking end-to-end support and partner with a design-build firm that offers in-house program, project, and construction management services, as well as commissioning and operational readiness capabilities. These design and build experts help owners seamlessly integrate every aspect of project delivery from concept to turnover.

This proven method, with the right type of firm, saves time and money. Design-build integrated project delivery (sometimes called EPCMV) is often the choice for smaller firms with fewer resources or larger firms with project managers who have an overwhelming number of competing priorities and want to quickly get to market. The process is simplified with one contract, one point of contact, and one price. The model should be customizable as well.

Adequate In-House Resources but in Need of Additional Support?

For project owners who have adequate in-house resources, time, and experience, and are willing to manage multiple contracts, you may prefer a less high-touch approach. Contracting an effective owner’s representative, just one service or a combination of program, project, and/or construction management services, likely fits the bill.

Larger organizations with in-house engineering, construction, and commissioning teams sometimes need help with just one specific aspect of the project – like project controls or cost estimating. Even if they have in-house teams, owners with multiple competing priorities often subcontract external services and simply manage the work of skilled teams for various projects.

As you kick off your capital investment project, it’s important to know what level of support you will need to streamline the building process. A good program manager is approach-agnostic and will help you determine the right type of delivery method to suit your needs, will vet the pros and cons of various locations, teaming partners, and alternative solutions. Program managers also can assist with defining user requirements and scope development so that you are not over or under designing for your project needs.

The graphic below outlines the various phases of integrated project delivery and walks through the activities that occur at each project phase. It begins with the idea (or conceptual phase) where critical programming starts and moves through the design, construction, commissioning, and operational readiness phases. The graphic ends with the turnover of a high-quality, fully operational facility that meets the owner’s vision and needs.

Typical End-to-End Project Life Cycle

Click to expand +

More About Why a Program Manager Should Be Your First Contact

Often project owners, especially first-time capital project managers, are unclear about who their first point of contact should be when thinking about starting a new project. Success is often enhanced by involving a qualified, experienced construction program manager with the technical acumen required to keep your life sciences project on track from the start.

Program management firms look at construction projects in a holistic way, rather than focusing on one discrete aspect of the build. Their approach is pragmatic and driven by functionality rather than only aesthetics, cost, or any other single variable. The best construction program and project managers often have experience as project owners or directors of facilities for life sciences organizations and understand sanctioning processes, scope development, and design and construction nuances.

Program managers excel at knowing the most important decisions to make in the early stages of any project, a key part of saving costs and expediting timelines. If needed, construction program managers can also help you develop user requirements that will better guide project teams as you define the scope of work. They ensure there are no gaps in design and provide as-needed solutions for complex challenges the best way to scale the business while keeping the budget top of mind.

Examples of areas to focus on early before you select a designer, developer, or commercial real estate agent:

Budget & Schedule

Consider items such as regulatory requirements, state and local permitting timelines, code requirements specific to location, and long-lead materials such as HVAC and electrical equipment.

Site Needs

Factor in must-know soil conditions and remediation needs, site history, utility availability, and other elements that may impact the project design or development.

Scope Development

Identify critical project elements such as spec humidity, scalability plans, flexibility (especially if still in the trial phase), and impact of outside elements such as vibration from aircraft or trucks (for specific types of work).

Design Decisions

Identify the pros and cons of big decisions such as opting for a prefabricated modular build vs. stick-build, using concrete vs. steel, and other major design calls. Early decisions can make a huge impact on cost, schedule, and flexibility of the facility.

Other common challenges program managers assist with include:

  • Developing the business case for the project to present to your board of directors or capital approval committee
  • Asking leading questions that can help to design the project with flexibility to scale in the future
  • Identifying the best contract and procurement methodology for the project
  • Developing accurate budgets, visibility analyses, constructability reviews, and risk analyses to ensure you are prepared for any potential scenario
    • Example: one project we worked on had originally planned for 11 skin systems, which would have created multiple unnecessary points of potential failure. To reduce variation and improve user efficiency, we helped the project owner simplify the design to include only three
  • Selecting the perfect site without bias
  • Building out the larger project team — commercial real estate agent or developer, architect, engineer, general contractor, etc. — that are best suited for your type of project
  • Deciding whether it makes more sense for you to own the facility or lease it

Selecting Where to Build

Each year, Boston and San Francisco top the list of top life sciences clusters in the United States. However, home of the fourth-largest biotech hub and the ninth-largest biopharma cluster in the country, North Carolina is a hidden gem in the life sciences sector. The state, especially areas near Research Triangle Park, offers a host of benefits and incentives for companies looking for a place to begin or expand their footprint.

Site selection depends on several factors, and a program manager can help you weigh the pros and cons of various locations. Important questions to consider include:

  1. Is access to highly trained talent a major factor in your plan?
  2. Are you looking for proximity to other major players like Pfizer, Novartis, Seqirus, or AstraZeneca?
  3. How does funding (or lack thereof) stand to impact your plans for expansion?
  4. How will you weigh speed-to-market and budget with the ability to lease your site to other types of life sciences organizations if plans go awry?
  5. Would you like to expand your footprint to the East Coast?
  6. Is a lower-than-average cost of land/living important to your site selection?

North Carolina has all the bells and whistles of the larger life sciences clusters with none of the drawbacks (i.e., high cost of doing business), making it a no-brainer for many cutting-edge biotech and biopharma companies. The confluence of several factors make it a prime location for innovators like Fujifilm Diosynth Biotechnologies and Merck, to name just a couple of major local players.

Life Sciences Appeal in North Carolina
Raleigh Life Sciences Infographic

For starters, North Carolina offers a significantly lower cost of doing business than many of the other major clusters in the country — like San Francisco or Boston. The price and availability of land are much more accessible than in these more traditional metropolitan cities, which can make the justification and budgeting processes significantly easier. As an added bonus, North Carolina has recently been named America’s Top State for Business.

Furthermore, North Carolina also has a highly educated population due, at least in part, to its three Tier-1 research institutions, 58 community colleges, five medical schools, four pharmacy schools, and 36 private colleges. And many of these organizations offer training programs that help their students learn and hone the skills needed to secure lucrative careers in the life sciences industry.

The presence of hundreds of life sciences organizations and the ongoing emergence of even more has led to the development of an ecosystem that caters to the needs of life sciences innovators. Whether you are looking for lab space, collaborators, or funding, the Tar Heel State delivers.

A Sample of Notable Life Sciences Organizations with a Presence in North Carolina

35 North Provides Project Management Services for GRAIL
Novo Nordisk logo
Pfizer logo

Your Advantage: Our Deep North Carolina Roots

If you are considering relocating and expanding into North Carolina’s hub of life sciences innovation, our team would be happy to help you determine what is best for your organization and project. We have deep roots in the state, longstanding relationships with superior vendors, and an unmatched knowledge of the area. Reach out to connect with one of our experts who can help you chart your path forward.

35 North President and CEO Scott McEntee

Scott McEntee is the president and chief executive officer for 35 North. He is the founder of 35 North and has 30 years of industry experience, including over $2 billion in construction experience.

35 North Director of Project Management Services Pablo Hernandez

Pablo Hernandez is the director of project management services for 35 North. He brings 25 years of practice in engineering, project management, and site operations in the compliance-focused life sciences industry.

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