5 Questions With Akshay Nadkarni, Director, CMC Program Management, Kymanox
February 8, 2024
| This article is part of our 5 Questions With series, one of our ongoing People & Places Features. We love it because despite the consistent questioning, the answers are all unique. Be sure to FOLLOW us on LinkedIn to tell us what you think. |
Akshay Nadkarni is a Director, CMC Program Management at Kymanox, with 12 years of experience in implementing risk-based approaches to drug product, medical device, and combination product development. He is currently also serving as the Interim Head of the Kymanox Program Management Office.
Akshay’s drug product development expertise includes formulation development, analytical method development and validation, GMP manufacturing process development, scale-up and technology transfer, and clinical packaging and distribution for multiple drug products across multiple dosage forms. He has expertise in ISO 13485-compliant design, manufacture, and release of medical devices and combination products, and design and construction of GMP manufacturing facilities for production of clinical drug products. Akshay has prior experience providing quality assurance support for GMP operations and has authored CMC modules for multiple FDA and EMA regulatory filings.
He holds a Bachelor of Science in Biomedical Engineering degree from Duke University and a Master of Science in Biomanufacturing degree from North Carolina State University. His graduate research focused on designing novel downstream purification processes for monoclonal antibody drug products.
1. What did you want to be when you grow up? How’d you get from there to here?
As early as high school, I knew I wanted to be involved in the life sciences/healthcare industry in some capacity. I remember thinking about the most impactful way I could help people in need, and developing new therapies or treatments for novel diseases really interested me.
In college, I worked in a research lab developing mathematical models to map out how efficiently drugs could diffuse through tissues – that in turn led me further down the path of drug formulation development and drug product manufacturing process development.
I decided to specialize my education in manufacturing process development for biologics therapies, and that is how I got my start in this industry. From there, I further branched out into medical device and combination product development across multiple dosage forms and therapeutic areas.
2. How are you helping to build a more connected community?
BioBuzz’s mission is simple: to be more connected. Our regionally-focused storytelling, programs, events and experiences create, connect, and amplify impact across the life science workforce in growing biohubs. We vibe with people who value community and connection like us. We’d love for you to share how you’re building a more connected community… and any support that you need from our community to continue to accomplish this mission.
One of the opportunities of working at Kymanox is getting to build relationships with thought leaders in multiple aspects of the product development lifecycle. We often work with small companies or start-ups just beginning their development journey. We are always excited to connect these companies with thought leaders in the areas they need assistance with – be it as broad as regulatory strategy or formulation development, or as specific as sterilization validation support or analytical method development – with the outcome of fostering emerging therapies with best-in-class development support.
3. What are you currently buzzing about? Anything and everything…
I’m deeply grateful and excited to contribute towards the development of impactful and life-saving therapies through my current role with Kymanox. I’m especially excited about the products we’ll be able to take to the finish line for commercial approval in the upcoming year – some of which are the result of multiple years of development and long-term partnerships with Kymanox.
On a personal note, I’m excited to step into my new role as ‘Dad’ – my first child was born in July 2023 and every day raising him is a wonderful and fun adventure!
4. If you could travel back in time – what early career advice would you give yourself?
The first piece of advice – dedicate time each week or month to reach out to coworkers and colleagues in your industry and make as many connections as possible! Send a quick message on LinkedIn or set up a 15-minute coffee chat to learn more about who your colleagues are, their backgrounds and interests, and what they do.
The second piece of advice – keep an open mind to opportunities that come your way! Careers can take many twists and turns, and your personal preferences, priorities, and development focus may change as you go along. Take stock of these things every once in a while to make sure you capitalize on new opportunities when they come up, even if they take you in directions you previously weren’t considering.
5. FUN question. Give us your top 10 list for the Best of RTP.
My favorite restaurants in the RTP area, in no particular order:
- M Sushi (Durham)
- Vin Rouge (Durham)
- Il Palio (Chapel Hill)
- Second Empire (Raleigh)
- Death and Taxes (Raleigh)
- Rue Cler (Durham)
- Bin 54 (Chapel Hill)
- Littler (Durham)
- Vivace (Raleigh)
- St. Jaques (Raleigh)
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.
