Blending Science and Manufacturing in Pharmaceutical Development

A featured contribution from Leadership Perspectives: a curated forum reserved for leaders nominated by our subscribers and vetted by our Manufacturing Technology Insights Advisory Board.

Novugen Pharma

Blending Science and Manufacturing in Pharmaceutical Development

Balancing Traditional Methods with Emerging Technologies

At Novugen, I’m an Associate Manager where I get to blend science with daily trial batch execution. Every day, I work with my team to develop new generic drug formulations, optimize manufacturing processes and take breakthrough ideas from the lab to full-scale production.

My day-to-day involves:

• Leading my team for development of generic solid dosage forms, especially immediate-release and specialty drugs— turning concepts into viable products.

• Guiding scale-up efforts for advanced techniques like Wurster coating and drug layering, making sure we can produce efficiently at commercial levels.

• Working closely with Quality, Regulatory and Manufacturing teams to balance innovation with compliance and practicality.

• Coaching junior scientists, helping them grow their technical skills and leadership abilities.

Early in my career, I saw R&D as this linear process: you follow the textbook, optimize the known variables, and boom - you’ve got a viable product. But working with both traditional methods and newer technologies has completely shifted that mindset.

For example, with established techniques like wet granulation or compression, there’s comfort in predictability - you know how things will behave at scale. But when you start integrating emerging approaches (say, continuous manufacturing or advanced drug-delivery systems), you realize how much room there is to challenge assumptions.

Now, I see R&D as more of a balancing act: respecting the fundamentals while staying open to reinventing them. A formulation might start with a classic approach, but maybe we tweak it with a novel excipient or an AI-driven process optimization. The key is knowing when to lean on proven methods and when to take calculated risks - because at the end of the day, the goal isn’t just scientific elegance; it’s getting better treatments to patients efficiently.

Scaling Up With Precision and Practicality

Working with technologies like Wurster coating and drug layering has taught me that scaling up isn’t just about making things bigger - it’s about understanding the why behind every parameter so you can replicate success reliably.

For example, in Wurster coating, something as simple as airflow or nozzle size can make or dissolve your drug layer. Early on, I learned to map out how each variable (spray rate, bed temperature, powder properties) impacts coating uniformity. By nailing this at lab scale, we avoid nasty surprises later.

The same goes for equipment. A lab-scale fluid bed works differently than a production-scale one—baffle design, batch size, even humidity control matters. I’ve spent time with engineers and operators on the floor to see how machines actually behave, not just how they’re supposed to. That handson insight helps me design processes that are robust enough for shifts, maintenance, and real-world variability.

“At the end of the day, the goal isn’t just scientific elegance; it’s getting better treatments to patients efficiently”

At the end of the day, consistency comes from respecting both science and machinery. If you understand how each parameter affects quality (say, ensuring drug layering adhesion stays intact during scale-up), you can tweak intelligently instead of guessing.

Cultivating Curiosity, Precision, And Continuous Learning

Curiosity and experimentation are the heart of formulation development work – they are how we turn “what if?” to “here’s how.” Every day starts with questions: Could this ingredient enhance stability? Would optimizing process be able to solve capping issues? I thrive on testing those hunches, whether it’s tweaking a binder viscosity, or exploring new excipients. But it’s not just about trial and error; it’s about targeted curiosity. I pair open-minded exploration with structured hypotheses, so even “failed” experiments teach us something.

Precision and creativity might seem at odds, but in formulation, they are partners. I carve out space for both by:

1. Grounding creativity in science: Playful ideas get a reality check via literature reviews or bench-scale tests – so imagination doesn’t outpace feasibility.

2. Leaving room for serendipity: Sometimes the best discoveries happen when a “mistake” reveals unexpected performance. I’ll ensure everything to be documented to capture those moments.

3. Iterating with purpose: Creativity fuels the first draft of a formula; precision refines it. I cycle between bold moves and meticulous adjustments - like balancing the pore former and polymer to ensure release can be controlled as desired.

At its core, formulation is problem-solving with flair. The fun lies in dancing between “let’s try this” and “let’s prove it works.”

One critical piece of advice is to cultivate a mindset of continuous learning, both technical and interpersonal.

In pharma, regulations, technologies, and best practices evolve rapidly, so staying ahead requires proactive curiosity (e.g., understanding new FDA guidelines, emerging manufacturing technologies, or digital transformation in operations).

Equally important in developing soft skills. Learn to communicate clearly across functions, empower your team through delegation and mentorship and navigate challenges with adaptability. Leadership isn’t just about expertise, it’s about fostering collaboration to deliver safe, efficient, and innovative solutions.

Finally, cultivate patience with processes and people. Drug development is a marathon; your ability to keep teams motivated through setbacks will define your leadership more than any single triumph.

The articles from these contributors are based on their personal expertise and viewpoints, and do not necessarily reflect the opinions of their employers or affiliated organizations.