Early Planning for Operational Readiness

Authored by Michelle Sinsel, Sr. Director

Operational readiness in the pharmaceutical and biotech industries is a complex effort involving people, procedures, materials, equipment, and processes to produce quality therapies at new cGMP facilities. While design, construction, and CQV are crucial, operational readiness is equally vital.

Strategizing should ideally begin in the design stage, coordinating with construction and CQV partners and internal experts. Early planning allows project leaders to oversee each function's contributions, track progress, and use PM tools, analytics, and risk-based scenario analyses.

Operational readiness should be integrated into the entire facility delivery process, ensuring a smooth transition from design to cGMP production. Delaying this planning can lead to missed opportunities and delays. The right approach ensures the right people and processes are in place to manufacture therapeutics efficiently and compliantly.

Strategic Staffing: Timing Your Key Hires

Identifying the need for key strategic positions early prepares you for future operations. While it may be tempting to delay hiring operational staff until the facility delivery is well advanced, this can have drawbacks. Early input from experienced personnel is crucial for equipment design, operational workflows, and supplier selection. These experts can realistically assess utilization, maintenance, and quality considerations.

During construction, commissioning, and equipment qualification, operational resources can observe the facility, test equipment, train with vendors, and understand system integration. Early hiring allows for effective troubleshooting, pre-qualification improvements, and developing internal knowledge to train future staff.

However, early staffing comes with costs, as non-revenue-generating positions impact the bottom line before commercial manufacturing begins. Each company must balance hiring timing with advantages and disadvantages, considering financial factors and the cGMP labor market in their location.

A common solution is to hire crucial positions early: process engineers, manufacturing supervisors, process mechanics, quality associates, and automation engineers. This core group will learn the equipment, establish core cGMP processes, troubleshoot operations, and train future employees. These key players must fit your company’s culture, fill multiple roles, and demonstrate curiosity and a willingness to learn.

Balancing Early Hiring and Return on Investment

When looking at the whole lifecycle of a project, it’s important to balance capital and operating expenses. For high-profile, high-velocity products in a supply-constrained environment, time to market is key to significant ROI. In such cases, leaning into the operating budget in the short term is often worthwhile, as waiting to hire personnel can cost more in the long run. Delaying your drug by even days or weeks in a competitive environment allows competitors to capture market share.

A new cGMP facility can have the best equipment, systems, and processes, but these investments are ineffective without experienced operations and quality staff to make, test, and release quality cGMP batches. If your processes are not well defined and staff isn’t knowledgeable or adequately trained and qualified, the manufacturing process can be delayed or risk not meeting regulatory criteria for licensure and ongoing cGMP compliance. Early hiring, aligned with your project’s timeline and objectives, can be a wise investment, setting the stage for a compliant and operationally effective facility.

Preparing for Technological Readiness

Operational readiness also involves technological readiness for manufacturing. This goes beyond purchasing the right equipment to understanding the entire step-by-step process for creating these therapies. Greenfield facilities are particularly challenging because they often develop their processes while designing and constructing the facility.

The facility’s and process’s capabilities guide decisions on materials, equipment qualification ranges, written procedures, systems, and workflow. Anticipating these during the design stage helps avoid costly and time-consuming future course corrections. An experienced person can translate two-dimensional ideas into three-dimensional realities, identifying design flaws before expensive corrections are needed.

It’s impossible to anticipate every issue while preparing your facility. A core, cross-functional team of operations and quality resources early in the project can bring diverse perspectives to identifying risks and providing quick, sound solutions in the design and construction phases. This team builds flexibility into the project strategy, allowing companies to pivot when necessary.

Final Thoughts

Early planning for operational readiness is a pivotal factor in the success of pharmaceutical and biotech manufacturing projects. It involves assembling the right team at the right time to prepare for technological advancements and ensure a smooth transition from design to cGMP production. Waiting until later in the project can lead to missed opportunities and delays. This proactive approach enables project leaders to have a comprehensive view of each function’s role and progress, facilitating a fully operational facility.

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About Project Farma

Project Farma, a Precision for Medicine company, specializes in providing comprehensive biomanufacturing strategies and execution services. We have successfully industrialized over 10 commercial cell, gene, and novel therapies, executed 60+ facility builds and capital expansions, and managed $6B+ in technical operations capital investments.

With expertise spanning startups, leading life science corporations, advanced therapy organizations, universities, hospitals, government agencies, and more, our team delivers proven technical operations and manufacturing solutions that shorten time-to-market, helping patients in need.

Visit our website to learn more about Project Farma and how Precision for Medicine’s integrated capabilities — across labs, clinical trials, manufacturing, and data intelligence— can help your organization bring therapies to life.?