A CMC Playbook For Leadership And Hiring

By Louis Garguilo, Chief Editor, Outsourced Pharma

Would you like a shortcut to failure in regulatory CMC?

Hire extensively based on what candidates already know.

That’s a provocation underlying a number of conversations I’ve had recently with senior leaders in regulatory CMC, and it feels especially relevant to outsourcing.

Across companies, modalities, and outsourcing models, a consistent theme emerges: with the correct attitude, learning (yes, on the job) may beat credentials for long-term success.

The Myth of the “CMC Professional”

There is no master’s degree in Regulatory CMC (as far as I know). Yet biopharma organizations continue to search for “qualified” candidates who can foresee data needs from tech transfers to commercialization – and post-approval changes – often across multiple CDMOs and markets.

That’s not how some of the most effective leaders are building their teams.

Instead, they are building CMC professionals around curiosity and adaptability.

“Questions are our best friend,” one CMC leader told me.

Certainly, chemistry backgrounds and related others are valuable. But otherwise talented, communicative (and often younger) professionals can absorb regulations, systems, data capture, AI developments, and global regulatory expectations.

Writing and compilation skills, coordination capabilities, and a willingness to observe firsthand – including time spent at CDMO sites – are legitimate entry points.

What matters most is mindset, and that erstwhile term I’m hearing more of again, “emotional intelligence.”

Readers might ask: Are we so seriously applying concepts like curiosity, adaptability, and self-awareness to the rigors of CMC?

Increasingly, the answer to that is yes.

“If people are inquisitive and ask questions, they will grow into this role,” said a regulatory expert.

“If somebody has a PhD in chemistry, that is wonderful,” another added. “Chemistry sits beneath everything, whether it’s a biological product, a vaccine, or of course small molecule.”

“But this job itself can be learned. It is more about the ability to adapt and grow. The job is learning more than you know now. It’s a constant, evolving process.”

Learning As Risk – And Necessity

But like most everything else when it comes to leaders figuring out who and how to hire, this approach also carries risk.

A recognized risk, though, “that can be mitigated and managed.”

New regulatory CMC professionals must be “allowed to stretch” — following and learning to help guide programs across phases, and, fingers crossed, over years of service to an organization.

Shielding new or less experienced "CMC professionals" from responsibility doesn’t protect the organization as much as it delays the development of the function itself.

This discussion becomes even more critical in outsourced models.

If any group within a sponsor organization must understand exactly what a CDMO is doing—and how changes ripple through regulatory submissions and markets – it is CMC.

The job is learning more than you know now. And you can get that education directly by going to your own manufacturing plant or to that of your CDMO and see what they’re doing.

Moreover, paradoxically perhaps, hiring for learning potential rather than experience can create greater continuity, and the flexibility needed when working with external partners.

Organizations that nourish recruits, reward curiosity, and expand roles into end-to-end ownership of CDMO-facing projects often find their CMC teams become a source of long-term strength.

CMC As Strategist, Not Just Tactician

Regulatory CMC will always involve assembling documents. But much of that work is increasingly standardized, templated, and automated.

What remains irreplaceable is interpretation.

Regulatory guidances evolve. New concerns emerge – nitrosamines, excipients like titanium dioxide, or shifting expectations tied to advanced manufacturing.

Meanwhile, outsourcing relationships are anything but static. CDMOs change strategies. They get acquired. Personnel turns over. New sites come online while others are phased out.

In that environment, CMC professionals must operate as strategists as well as detailed tacticians.

A change today raises immediate questions: What does this mean for future development or manufacturing? For cost, yes – but also for regulatory pathways, submission strength, and approval timelines?

SOPs, materials, and data expectations can appear stable until someone asks the right question.

And often, it is the less-tenured employee – the one not yet conditioned by “how things have always been done” – who asks it.

A CMC And CDMO Match

There are new demands on regulatory CMC. “The role is even more critical,” one CMC expert told me, “because we must be more data-savvy, able to review and interpret, navigate evolving systems and changing guidances, and emerging issues.”

Even in the advent of AI, there is so much administrative work involved, but also the broader strategic responsibility as that digital transformation or AI-enabled processes affect submissions.

“The CMC skillset requires constant evolving,” seems the mantra.

The role is also becoming more evaluative.

CMC Professionals should play a role in assessing CDMOs early, by looking at reputation, compliance history, transparency, and operational consistency, and not as a secondary checkpoint, but as an input into a sponsor's outsourcing strategy and selection process.

On the CDMO side, the best distinguish themselves through technical capabilities and by how they build and support their own teams, e.g., how they train, communicate, and execute.

If a CDMO cannot demonstrate stability, reliability, and adherence to protocol, while also evolving, the market will respond accordingly.

In that sense, CDMO leadership begins to mirror what strong CMC leadership looks like at sponsors they work with.

Which brings us back to something else I’ve heard more than once.

“Leadership is not about creating fear of authority,” executives say (and countless books on leadership point out). It’s more about accessibility, empathy, and self-awareness.”

A reference back to my comment on emotional quotient.

“You need to know your own triggers, separate problems from people, and create space for voices that challenge you,” one leader with years of Big Pharma experience says.

Tellingly, those are also the types of qualities sponsors should look for in their CDMOs as well, along with specific skillsets, knowhow, capabilities and capacities, etc.

Which begs the  question (CMC is always asking questions):

What is the discernible quality of leadership inside the CDMO you are considering working with?

Is it evident in the people working on your programs?

An engaged, inquisitive CMC team at the sponsor, matched with an equally open and questioning culture at a CDMO, ultimately drives successful regulatory outcomes.

Years on the job are not the benchmark of the future of our industry. Learning (under enlightened leadership) should be. And that may lead to the years of experience we have sought in our CMC professionals.