8 steps towards effective project management in pharmaceutical manufacturing

Robust project management is essential in any manufacturing business, particularly where strict regulations and complex production processes require maximum alignment between all involved functions.

As a Contract Development and Manufacturing Organisation (CDMO), Bachem has developed unique expertise in project management approaches and systems. CDMOs play a crucial role in supplying Active Pharmaceutical Ingredients (APIs) to biotech and pharmaceutical companies, involving all required steps like raw materials management, process development and validation, production, purification, and delivery.

To ensure efficiency and clear ownership, designated project leaders (PLs) are allocated to oversee all aspects of the development process, serving as the primary customer contact, and coordinating team members.

The importance of effective project management in the pharmaceutical industry

Development and commercialisation of new drugs are immensely complex processes, with many parts moving in parallel to account for. As a result, project management is one of the most fundamental aspects of the pharmaceutical industry’s product life cycle. With numerous stages to manage, such as research, clinical trials, regulatory approvals, and manufacturing, each step requires satisfaction of stringent regulatory requirements as well as technically feasible processes. In addition, relationships between CDMO and pharma or biotech companies must be frictionless, with a cohesive partnership being the key to a successful collaboration.

Project management offers the solution. It facilitates efficient planning, communication, and project execution between pharmaceutical companies and their CDMO. PLs ensure deadlines are met, stay within budget, and maintain quality.

Moreover, project management allows for seamless collaboration between multidisciplinary teams and companies, enabling clear communication and streamlined decision-making – ultimately leading to faster product turnaround and more consistent product quality.

How can project management be improved?

Improving project management in any manufacturing industry requires a diverse approach, employing several key strategies:

1. Prioritise clear communication with stakeholders

Most importantly, communication is the factor which determines the success of a project. In most industries, large manufacturing projects will involve a number of stakeholders, including researchers, clinicians, regulatory bodies, and commercial partners. Thus, project leaders must enforce consistent and coherent communication channels to ensure alignment on project goals, timelines, and expectations as well as sharing of data using secure platforms. Similarly, setting up regular team updates, an agreed means of reporting, and offering routes to address concerns when they arise can promote trust between stakeholders, improving chances of a successful project outcome.

2. Facilitate and promote cross-functional collaboration

Most projects will involve collaboration between multiple teams across various disciplines and areas of expertise both within pharma companies and their CDMOs. From research and development, to clinical operations, regulatory affairs, and manufacturing, a successful project requires seamless working across the wider team network. 

The same is true for cross-departmental collaboration within a CDMO to develop and validate compliant and efficient product manufacturing processes. Promoting collaboration among teams is crucial to allow knowledge sharing, while helping all those involved gain a better and more rounded understanding of the project’s challenges and opportunities. To ensure this, project leaders should look to cultivate a working environment that encourages sharing of different viewpoints and open communication.

3. Establish a culture of honest and open feedback 

Added to this, project managers should promote ongoing and honest feedback to expedite improvements to practices. By regularly evaluating progress and conducting project reviews, companies should be able to identify areas for improvement, address challenges, and make adjustments. 

Whether it’s positive or negative, constructive feedback can be a huge factor in helping to optimise processes and ultimately improve decision-making.

Furthermore, input from external stakeholders can offer unique insights to identify areas for improvement, refining strategies to meet industry best practices.

4. Assign defined responsibilities

In complex manufacturing projects, clear, defined roles and responsibilities for each team member are essential. Project leaders must ensure team members have complete clarity on their responsibilities, deadlines, and their assigned functional deliverables. Resultingly, this prevents overlapping work, reduces uncertainty, and encourages individuals to own their work and take accountability for their actions. And, creating a robust governance structure both within each partner company and shared, with clear routes for escalating issues can streamline decision-making, helping resolve problems more efficiently.

5. Practice proactive planning to stay ahead

Proactive planning is fundamental to effective project management. Project leaders must prepare for potential risks and challenges early on in the planning stage, and create contingency plans to mitigate disruptions accordingly. 

Alongside this, project managers should make use of project management tools and technologies that can aid campaign planning, monitor progress, and identify potential bottlenecks or disruptions.

Throughout the manufacturing process, regular reviews and adjustments will give projects the best chance to remain on track and aligned with evolving business goals. For example, at Bachem, we use a robust, yet flexible Chemistry, Manufacturing and Control (CMC) framework for the development of New Chemical Entities (NCE, or new drugs) for our customers, to ensure the seamless progression of processes and deliverables. 

6. Review and develop new ways of working throughout the project

Project management practices should be continuously reviewed and refined to adapt to changing regulatory landscapes, technological advancements, and industry best practices. Encouraging a culture of continuous improvement can help identify and implement more efficient ways of working. This may involve adopting new project management methodologies from the Agile toolbox, leveraging emerging technologies, or streamlining processes based on lessons learned from previous projects.

Regular training and professional development opportunities for project managers and team members are also essential ways to enhance project management capabilities.

7. Monitor risk at every stage

In the pharmaceutical industry, risk management is particularly critical, but vital to any manufacturing business nonetheless. In Bachem, we invest in a robust CMC framework that allows us not only to identify, but more importantly analyse and address potential manufacturing risks.

Large projects can be easily derailed by a multitude of factors, including changes to regulatory requirements, safety concerns, technical difficulties, or supply chain disruptions. Project leaders should include robust risk management practices into daily project team routine to identify potential risks early, documenting them, and evaluating their potential impact and producing necessary mitigation plans with regular follow-up actions.

Monitoring risks and communicating these regularly to all internal and external stakeholders can help to ensure that many risks are addressed proactively and impacts mitigated through thoughtful preparation of alternative scenarios.

8. Efficiency is vital in order to meet demand

Efficiency is key to effective project management, especially in the strictly regulated pharmaceutical industry with a generally low likelihood that products starting development will ever yield commercial benefits. With poor resource management and timekeeping, time-to-market can be significantly impacted, thus damaging patient outcomes and commercial success.

Project leaders must actively seek opportunities to improve processes, by optimising resource allocation, and eliminating needless activities. This could involve utilising Lean Manufacturing tools, embracing automation of appropriate tasks, or employing productivity-enhancing technological solutions tailored to the product’s need. By adhering to this approach and using a well-defined, efficient and flexible CMC framework, Bachem ensures the delivery of (hundreds) of project milestones across a large number of projects and customers.

Furthermore, implementing an organisation-wide culture of continuous improvement can contribute to better project outcomes, by encouraging team members to problem-solve and optimise processes from the ground up.

The ideal project management team

When it comes to managing a manufacturing project, no matter the scale, a wealth of knowledge and skills are required.

The ideal project management team will offer a tailored approach, with dedicated Project Leaders and both qualified and project-experienced members to oversee every step of the process. For example, project management specialists at Bachem strive to facilitate strategic decision-making and strategy development in the most customer-centric way possible, while enabling seamless effective cross-functional team working. Successful project management requires constant monitoring and reporting to keep your project on track and aligned with your objectives.

Commitment to innovation, quality, and customer success is key, if a project manager is to transform a project’s vision into reality.

Transforming project outcomes through effective project management

Effective project management can be the difference between a successful and unsuccessful project and collaboration. PLs play a crucial role in managing projects, optimising development of products, and ensuring regulatory compliance to help companies navigate the complexities of market authorisation.

With an experienced team, a structured approach, and customer-centric solutions, manufacturing businesses can ensure frictionless production from raw material sourcing to delivery of the final product.