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Top 10 Red Flags to Watch for When Comparing CDMOs

  • Writer: Sarah Sink
    Sarah Sink
  • Aug 3
  • 3 min read

Choosing a CDMO isn’t just a sourcing exercise. It’s a strategic decision that can either propel your program forward or introduce risk, delays, and unnecessary cost.


In business development, I’ve seen plenty of proposals that looked promising on paper only for the partnership to hit friction once execution began. By the time you realize a CDMO isn’t the right fit, you’re often locked into a timeline, a budget, and a relationship that’s tough to unwind.


So how do you avoid that?


You learn to spot the red flags early.


Here are ten signs I’ve learned to watch for. Most of which won’t show up in the pitch deck but can tell you everything about long-term fit.



1. No Questions About Your Program


If a CDMO is eager to quote your project but asks no clarifying questions, especially about timelines, materials, or risk factors, that’s not efficiency. That’s a miss. A true partner wants to understand the context, not just the content.



2. Every Answer Is “Yes”


If it feels too easy, it probably is. A credible CDMO will tell you what’s feasible, what’s a stretch, and what needs to be scoped further. A team that says yes to everything likely hasn’t thought through your program's complexity.



3. No Transparency Around Capacity


“Q4 availability” isn’t a capacity plan. You want to understand what internal resources your program will compete with, especially around tech transfer, batch scheduling, and analytical bandwidth.



4. The Proposal Is Light on Assumptions


If the quote shows numbers but no assumptions, run. Scope without context is meaningless. The CDMOs that earn long-term trust are the ones who show their work; the good, bad, and messy.



5. Inconsistent Communication


Delayed responses. Vague answers. Long gaps between meetings. Early communication is a preview of how they’ll show up once the work starts. If it’s disjointed now, it won’t magically improve post-award.



6. Heavy Commercial, Light Technical in Calls


The best proposals are supported by technical leads who engage early, not just a BD rep walking through a slide deck. If your team can’t get time with an SME pre-award, how available will they be during execution?



7. No Mention of Risk or Change Management


If the proposal or call doesn’t include how the CDMO handles risk, scope creep, or change orders, you’re flying blind. These things happen in every program. You want to know upfront how they’ll respond.



8. Overly Generic Timelines


If your proposal has a beautiful Gantt chart but no real tie-back to lead times, raw material availability, or resource constraints… pause. Ask them to explain how they built that timeline and what could shift it.



9. Lack of Post-Award Clarity


Who runs your kickoff? How are milestones tracked? What happens if a batch fails? If post-award execution is hand-waved with “we’ll align once awarded,” that’s a red flag. Great CDMOs have a plan and can articulate it.



10. They’re Not Evaluating You, Too


Good CDMOs don’t say yes to every project, and you don’t want them to. If they’re not asking you questions about your internal readiness, your data package, or your program’s risk profile, they’re likely not filtering for fit. And if they’re not doing that now, they may not push back when it matters later.



Don’t Just Spot the Red Flags, Plan Around Them


These red flags aren’t just warning signs; they’re opportunities to ask better questions, align internally, and course-correct before committing.


If you want a structured way to evaluate CDMOs beyond just quotes and capability decks, I’ve created a suite of tools and resources designed specifically for biotech teams like yours:



Each one is designed to help your team ask smarter questions, spot issues early, and build more resilient partnerships before the kickoff call ever happens.




For more insights and personalized support in navigating the biotech-CDMO landscape, visit my website: www.yourpharmagirl.com and follow Your Pharma Girl on LinkedIn. Whether you need strategic guidance, tailored BD solutions, or expert advice on building lasting partnerships, I'm here to help you and your team succeed at every stage of development.

 
 
 

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