Scientist Snapshot | Mike McCoy, Director of Toxicology and Industrial Hygiene

Director of Toxicology and Industrial Hygiene, Mike McCoy is a dual certified toxicologist and industrial hygienist with over 17 years of experience in the industry. Read more about how he supports our customers and their containment strategies below.

Can you briefly describe your education, background and current role at Sterling?

I have a Bachelor of Science in Medical Laboratory Technology and a Master of Science in Pharmacology and Toxicology. I am also certified by both the American Board of Industrial Hygiene as a Certified Industrial Hygienist (CIH) and a diplomate of the American Board of Toxicology (DABT). This dual certificate is rare, especially with having occupational toxicology experience in the pharmaceutical industry. It’s particularly unusual to have this specialty in-house at a contract development and manufacturing organization (CDMO).

I have spent most of my career working as a consultant in pharmaceutical industrial (occupational) hygiene and occupational toxicology. I have about 17 years of experience as an industrial hygienist and toxicologist, working for several consulting organizations including Stantec, Exponent and CTEH. I was a consultant for Sterling for several years before joining full-time as Director of Toxicology and Industrial Hygiene in September 2024.

At a high level, my role involves keeping employees safe by assessing the potential toxicity of the raw materials and active pharmaceutical ingredients (APIs) that we develop and manufacture at our sites. This involves evaluating and managing exposure through the air, establishing appropriate exposure limits and the controlling exposure to these materials. I am also responsible for working to streamline our global toxicology program, for example supporting containment strategy and aligning operational exposure limits (OELs) across our network of facilities, in line with our One Sterling ethos.

Having this capability in house brings a lot of value to our customers as we can quickly evaluate toxicity. A lot of organizations rely solely on external experts, but having the capability on site allows us to respond with speed and flexibility to our customers’ project needs and removes the delays often associated with involving and briefing contractors.

Additionally, we can quickly assess the containment performance of our control equipment and isolators allowing for agile modifications to customers’ high potency API research, development and manufacturing needs.

How does collaboration with other departments across Sterling come into play within your role?

It’s a really collaborative process at Sterling. As a PDMO^®, or partnership development and manufacturing organization, we must be nimble and creative to meet our customers’ needs. Safety, as our CEO says, is our number one priority.

Our holistic approach is something I have observed as unique to Sterling; we plan together for safe and efficient manufacture, and in the case of high potency APIs (HPAPIs) for example, we are able to change containment strategy for each customer’s needs. Generally, all customers have a different process, and we need to understand where exposure risks lie and develop creative solutions for containment and keeping our people safe, while manufacturing our customers’ APIs.

I have been responsible for supporting a significant training program to help protect our employees. Not only for those working in manufacturing, but across a wide range of disciplines who are involved with projects of that nature, including engineering, maintenance and quality, to understand exposure and how to safely handle HPAPIs or the areas that handle them. For example, if a maintenance team member had to go in to a containment area, our training program ensures they are equipped with the knowledge to enter the area safely.

Other companies often rely too heavily on personal protective equipment (PPE) for employee protection and don’t have the necessary infrastructure to keep them safe. Our PPE is simply a safeguard in the event of loss of containment, and not to protect against exposure. Instead, we rely on engineering controls and speciality isolators for containment. That’s the right way to protect employees, and our aim is to continuously create and maintain a culture of safety to ensure we are doing our best to protect our people and get them home safely.

What trends are you seeing in the market?

We’re seeing a tremendous number of requests for HPAPI, specifically ultra-high potency API (UHPAPI) manufacturing. Even in this past year, we’ve seen huge growth. In my role, I get involved early in the proposal process to see what’s coming downstream; thinking about our containment capabilities for that material and how we would handle it.

When I started out in the industry, I never thought that the potency of APIs and drugs would be what it is today. The opportunities available now, such as the warheads we manufacture particularly for oncology drugs and specialty diseases, are incredible. Earlier in my career, we were working in the 100s of micrograms range.

Today, at Sterling, we operate in the less than 10 ng range. That’s an incredible order of magnitude less now, and it makes my role incredibly rewarding. Few companies have the depth of knowledge that Sterling has. I’ve worked with customers struggling to get to the microgram range, as they haven’t had the physical plant or containment required to go further, but the investment that Sterling has made has really driven our ability to handle HPAPIs.

Read more about our HPAPI and ultra-high potency API offering.

What is your favourite part about working at Sterling?

I really enjoy my role at Sterling, and feel really good that the work I do goes towards protecting our people and safeguarding their future.