The role and mission of CMC : Expert Interview with Guillaume Germinet

To better understand the role and mission of CMC (Chemistry, Manufacturing, and Controls), we spoke with Guillaume Germinet, Business Projects Manager at SEQENS 

Watch the video here

Read the full interview here :

What is your primary mission as a CMC Manager at SEQENS? 

My role is to oversee all aspects of drug substance development—whether it involves an API (Active Pharmaceutical Ingredient), a regulatory starting material (RSM), or an intermediate—ensuring alignment with both regulatory standards and client expectations. I’m responsible for defining and executing technical and regulatory strategy throughout the product lifecycle, from raw material sourcing to manufacturing and quality control. 

Key responsibilities include: 

• Coordinating cross-functional teams (R&D, QA, QC, Regulatory Affairs, Manufacturing). 
• Developing and maintaining CMC documentation. 
• Managing timelines and deliverables for drug substance development. 
• Ensuring compliance with GMP and regulatory guidelines (FDA, EMA, ICH). 
• Acting as the technical liaison between clients and internal teams. 

How do you ensure project alignment with SEQENS’ capabilities? 

By thoroughly understanding both the client’s requirements and SEQENS’ technical and industrial capabilities, I ensure that development plans are realistic, scalable, and cost-effective. This alignment is essential to delivering high-quality outcomes within expected timelines. 

What technical knowledge is essential for a CMC Manager? 

A CMC Manager must have a deep understanding of: 

• Chemical development requirements (formulation, analytical methods, stability). 
• Manufacturing processes (scale-up, tech transfer). 
• Regulatory frameworks (ICH Q8–Q11, FDA/EMA expectations). 
• Quality systems and risk management principles. 

Could you explain to us the importance of your role, especially in terms of management? 

My role serves as a bridge between science, operations, and strategy. I ensure that all stakeholders—from R&D to manufacturing to regulatory affairs—are aligned on project goals and timelines. This requires strong leadership, clear communication, and proactive risk management. In biotech collaborations, building trust through transparency and agility is key. I lead multidisciplinary teams and ensure that decisions are data-driven and compliant with regulatory standards. 

What is your role in client interactions? 

I serve as the technical point of contact for clients, translating their needs into actionable development plans. I maintain transparency, manage expectations, and provide regular updates on project progress, risks, and mitigation strategies. 

What tools or systems do you typically use? 

To manage projects and documentation efficiently, I rely on: 

• Document management systems (e.g., Veeva Vault, SharePoint). 
• Project management tools (e.g., MS Project, Smartsheet). 
• LIMS and ERP systems (e.g., SAP, LabWare). 

As we know, launching a new drug substance on the market will face some challenges, you need to be adaptable. How do you face these uncertainties? 

As a drug progresses through clinical stages, new data often lead to changes in scope, process implementation, or scale. Agility is essential—especially in early-stage development—without compromising timelines. A problem-solving mindset and the ability to pivot quickly are critical to success. 

Can you share with us a success story where you had to overcome some significant challenges? 

One notable success involved a biotech partner who transferred an incomplete early-phase package. The analytical methods lacked robustness, and impurity profiles were undefined. We initiated a gap assessment, developed missing methods, and implemented a collaborative tech transfer plan. Thanks to structured communication and proactive risk management, we met the clinical supply timeline and avoided costly reformulations 

For improving the global environmental footprint, how do you manage these new considerations in  your organization?  

Improving the environmental footprint of the drug substance supply chain requires a comprehensive, multi-tiered approach that spans raw material sourcing, manufacturing, packaging, logistics, and waste management. 

SEQENS has 15 manufacturing sites, mainly in Europe, including 8 GMP sites.  Depending on the required capabilities of the project, we can produce vertically and internally all the different stages GMP or non GMP, with potential backups when needed. We can implement process intensification to reduce batch sizes, energy, and solvent use. 

Any final thoughts? 

Developing an industrial process for a new drug substance is complex and demanding. At SEQENS, we offer optimization programs to ensure that manufacturing processes are robust, efficient, and environmentally sustainable. Effective CMC strategies go beyond cost control—they create value by optimizing resources and fostering collaborative, flexible partnerships. That’s our commitment to successful drug development. 

Can you give us your background? 

By education I am a pharmacist and an engineer but also I hold a Specialized Master’s degree in Project and Program Management from SKEMA BS and the PMP certification from PMI with strong skills in strategic planning and cross-functional coordination. Prior to joining SEQENS, I worked in various roles within the pharmaceutical industry, including production manager, industrialization and process qualification, where I developed expertise in GMP environments, equipment qualification, and multiple dosage forms. My career path has always been driven by a passion for bridging technical excellence with operational efficiency.