From Biology Grad To Manufacturing Guru
By Louis Garguilo, Chief Editor, Outsourced Pharma
Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology and a question about what’s next: medical school and patient care? She’d always had a penchant for helping people.
But she began to broaden that inquisition. “I was thinking, what else can I do with this degree?”
An online search turned up an intriguing area – pharmaceutical manufacturing.
“It was manufacturing,” she says, “but I realized I could still help people. It might not be face-to-face, but you are making the drugs that patients need. That matters as much as any part of the industry.”
This isn’t just another project to fit into your schedule. Your work on this project has the potential to help millions of patients. Here is the data, the tech package, but also here are some of our patients’ stories.
Yes, pharmaceutical manufacturing is business – big business, profitable business, demonstrably the business of commerial success.
But from the get-go, Wimberly, a young female professional with a penchant for helping those in need, brought a foundational attitude to manufacturing that has served her well at some of the industry’s most recognizable drug companies.
A career stretch that has wound through a stint at GSK, nearly a decade at Shire/Takeda, and elevating levels of responsibility. Today she’s starting out with her own pharmaceutical-manufacturing consulting company.
Learning GMP The Real Way
“At GSK, I learned what manufacturing really meant,” she starts our conversation from her office in Covington, Georgia – “precisely following each batch record; having thorough quality checks, and having integrity even when no one is watching.”
In cGMP environments, even minor shortcuts can have large consequences. “A missed or not completely followed step isn’t just a procedural lapse — it can compromise a drug, and ultimately, a patient,” she says.
While she always felt connected to the end user, her next roles further deepened that sense of responsibility.
She moved into aseptic processing supporting advanced therapies for late-stage cancer patients when she joined Baxalta (later Shire, and eventually Takeda) as a manufacturing lead. The work was meticulous, high-stakes, and emotionally charged.
“It was tedious, but very rewarding,” Wimberly says. “You could see the outcome. Patients who might not have survived were getting treatment.”
Manufacturing had now thoroughly mixed with a preternatural sensibility. It was floor-level, practical work reliant on precision, accountability, and a constant connection between decisions and patient impacts.
“We were commissioning equipment, writing SOPs, job aids, job-hazard analyses — building the department from the ground up,” she recalls.
Beyond efficiently operating processes, now she was creating systems to support commercial production.
“I got to see everything, including from the start of the product in the vessel to purification and transfer to other sites for filling,” she says. “That full picture was huge for me.”
Soon, she was excited to be part of the people side of the organization. “I was now hiring, training, building teams,” she says. “Seeing someone grow from entry level to supervisor — that meant a lot to me.”
And with it all, she started to think more deeply about the external organizations taking part in the development and manufacturing of the company’s drug programs.
What’s It Mean For Outsourcing?
Over the years, Wimberly developed a clear view of what separates productive CDMO partnerships from, shall we say, painful ones. Much of it comes down to the preparation and presence from the sponsor side.
A common gap she sees is sponsors underestimating how much operational clarity they must bring to the relationship.
“You can’t just send a process and assume everything will translate perfectly,” she says. Batch records, critical parameters, and step descriptions must be written with the CDMO operator in mind, not the original development team.
“If something can be interpreted two ways on the floor, eventually it will be,” she says. For sponsors, that means to the extent possible, pressure-testing documentation before transfer, and during a project always being available to answer questions in real time, not days later.
She stresses that CDMO oversight extends well beyond formal “governance” meetings or quality agreements.
“You have to understand how their process actually flows day to day,” she says of CDMOs. Equipment changeovers, staffing patterns, and competing client schedules all affect the execution of your projects.
Moreover, CDMOs are not static; ownership, personnel, focuses and strategies can and do change.
Sponsors who take the time to understand those realities and the people involved – rather than managing by timelines and deliverables – are better able to anticipate bottlenecks, and adjust before they become deviations or delays.
A best practice is designing processes with human performance in mind. “People will make mistakes,” Wimberly says. “Your job is to make the right action the easiest action.”
Clear labeling, intuitive documentation, well-placed visual cues, and simplified steps are not minor adjustments. They serve as frontline risk control. In her experience, issues are often the result of systems that leave too much room for interpretation.
You want to achieve sanctioned innovation. You do not want unintended interpretations.
Ultimately, she says, harking back to her focus on patients, she encourages sponsors to view CDMOs “as operational partners who share responsibility for the patient outcome.”
Offer your manufacturing partners every opportunity for success. If they won’t take you up on those opportunities, you may want to adjust your supply chain.
“The more transparent and collaborative the relationship, the fewer surprises you or your CDMO operators will have,” she says. “When both sides understand the constraints and the goals, you get better performance and a more reliable supply for patients.”
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In part two, we’ll explore some of Stephanie Wimberly’s experiences as a black female working in a pharma-manufacturing milieu, as well as receive more of her advice.