We're excited to announce the newest additions to Kymanox. These talented professionals bring unique skills and experiences that will support our team and partners to continue bringing life science solutions to patients. Catherine Revels | Testing Analyst Ashley San Juan | Test Engineer Rachel Brunjes, MMB | Business Solutions Specialist Welcome to the team! We look forward to the great things we'll achieve together. Visit Kymanox.com to explore our comprehensive range of services and see how we're making a difference.
Kymanox
Biotechnology
Morrisville, North Carolina 6,622 followers
Your Life Science Solutions Partner - Bio | Pharma | Device | Combo ...because patients deserve better
About us
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive. By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride… because patients deserve better. Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
- Website
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http://www.kymanox.com
External link for Kymanox
- Industry
- Biotechnology
- Company size
- 201-500 employees
- Headquarters
- Morrisville, North Carolina
- Type
- Privately Held
- Founded
- 2004
- Specialties
- Technical Project Management, Process Operations, Engineering, Commissioning and Validation, Training, FDA PAI Assistance, Sustainability, Combination Products, Tech Transfer, Human Factors, Packaging, Quality Control, CMC Services, Product Development, MS&T, Supply Chain, Clinical Affairs, Regulatory, Medical Affairs, Microbiology & Environmental Monitoring, Audit, and Compliance
Locations
Employees at Kymanox
Updates
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𝐌𝐞𝐞𝐭 𝐭𝐡𝐞 𝐄𝐱𝐩𝐞𝐫𝐭: 𝐀𝐤𝐬𝐡𝐚𝐲 𝐍𝐚𝐝𝐤𝐚𝐫𝐧𝐢, 𝐃𝐢𝐫𝐞𝐜𝐭𝐨𝐫, 𝐂𝐌𝐂 𝐏𝐫𝐨𝐠𝐫𝐚𝐦 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐇𝐞𝐚𝐝 𝐨𝐟 𝐏𝐌𝐎 Akshay leads the Program Management Office at Kymanox, bringing over 10 years of experience in risk-based approaches for drug, medical device, and combination product development. Partnering with Akshay means leveraging his expertise to streamline your GMP manufacturing processes, accelerate scale-up, and ensure smooth technology transfers. His proficiency in authoring CMC modules for FDA filings helps navigate regulatory challenges efficiently. Akshay's strategic project management keeps your initiatives on track and within budget, maximizing ROI. His blend of technical knowledge and practical industry experience drives successful outcomes for Kymanox partners. To work with Akshay Nadkarni and his team, visit: kymanox.com #CMC #ProjectManagement
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Our latest podcast episode of The Factor is now live! We discuss the crucial role of maintenance personnel in medical device design. Learn how considering these 'invisible users' can lead to safer, more efficient healthcare technology. Listen now to gain insights that could add significant value to your approach to medical device development. Host: Lauren (Jensen) Horn, Ph.D. and special guest Avital Zik, Sr. Principle Human Factors Design Engineer at Medtronic and Rita Lin, M.S., RAC, Director, Human Factors Engineering at Kymanox and former FDA CDRH Human Factors Lead Reviewer. Subscribe: https://lnkd.in/eYDXYarv Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com
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"The day you graduate is just a milestone in your educational journey." Proud to have BioBuzz - Research Triangle (NC) spotlight our amazing colleague Saagar Patel! His expertise and continuous learning mindset make him an invaluable asset to our team. Follow to learn more about our talented team: Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com Subscribe: https://lnkd.in/eYDXYarv #medicaldevice #biopharma
Check out our latest 5️⃣ Questions with Saagar Patel, Principal Device Engineer at Kymanox! In this insightful piece, Saagar shares his career journey, community involvement, and the technological advancements that excite him. Read more: https://lnkd.in/e3FRcsRa #CareerJourney #EngineeringExcellence #CommunityBuilding #TechInnovation #MedicalDevices #AI #EV
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Kymanox CARES had a fantastic time supporting our friends at 3 Bluebirds Farm this weekend for their Take Flight Club. We learned about healthy eating habits and partnered with Inter-Faith Food Shuttle to make delicious frittatas using farm-fresh eggs and garden tomatoes. What local organizations do you love to support? Follow our journey to stay connected with our community initiatives! In partnership with: 3 Bluebirds Farm #DEIB #AutismAcceptance #Agritourism Special thanks to: Jenny Wieboldt Subscribe: https://lnkd.in/eYDXYarv Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com
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With over two decades of exclusive focus on the life sciences industry, Kymanox has become the partner of choice for companies worldwide. Our workforce of industry veterans, including former FDA officials, engineers, scientists, and chemists, offers unparalleled expertise to navigate even the most complex challenges. Follow us to unlock invaluable regulatory insights, cutting-edge solutions, and a seamless journey driven by cross-functional collaboration. Subscribe: https://lnkd.in/eYDXYarv Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com #lifesciences #biotech #pharma
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Too many balls in the air? In the product development lifecycle, it often feels that way, making effective multitasking nearly impossible. Don't let your hard work crash to the ground before launch. Kymanox is here to help you keep you on track, from risk management and resourcing to budget, technical support, and deadlines. With Kymanox dedicated PMO on your team, you'll have alignment across: • Development • Clinical • Tech Transfer • Commercialization • Lifecycle Management From regulatory affairs to product launch, we've got you covered. Let us handle the details so you can focus on innovation. Contact our team: Akshay Nadkarni | Frank Harrington | Natalie Davison | Courtney Newhall | Layne Barefield, PMP https://lnkd.in/eQ7iSwFG #ProjectManagement
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In case you missed it... We are thrilled to welcome William Monteith as our latest Kymanox Executive Advisor (KEA), joining Stephen M. Perry, Evan Edwards, Paul Jansen, and Mathias Romacker. With over 40 years of experience in biotech operations, including in Advanced Therapy Medicinal Products (ATMPs) and Cell & Gene Therapy (C>), William (Bill) brings invaluable expertise in strategic planning, regulatory compliance, bioprocess manufacturing, facility management, and supply chain optimization. His unique background and expert insights are a great asset for sponsors developing and commercializing modern medicine. And be certain the Kymanox team will leverage our top experts like Bill, our broader pool of 300 T-shaped professionals, key proprietary tools, and proven techniques to help your program succeed Right First Time (RFT)!
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This sounds like a cool Tuesday night with our local PDA Southeast Chapter. Join the fun tonight from 5:30 - 7:30 pm, and stay hydrated! Follow Kymanox to discover cutting-edge solutions and a seamless journey. Subscribe: https://lnkd.in/eYDXYarv Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com
☀ Beat the Summer Heat 🕶 and come cool off with some refreshing drinks and energizing conversations with your fellow colleagues. A fun night of industry #networking at Fortnight Brewing on July 16th 5:30 - 7:30 pm. No RSVP is required and you do not need to be a PDA member to attend. Bring a friend and be sure to select the attend button to help spread the word. Thank you to the PDA Southeast Chapter Annual Sponsors for making this event possible 🥁 Alcami Corporation STERIS FUJIFILM Wako Chemicals USA Quality CMC Consulting MilliporeSigma BA Sciences Kymanox Novatek International Azzur Group ValSource Inc. Charles River Laboratories Ecolab Veltek Associates, Inc. CONTEC, Inc. Innerspace - The Simulator Company LWS (Lighthouse Worldwide Solutions) Arcadis DPS Group Global Hope to see you there! PDA - Parenteral Drug Association
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Get to know why Evan Edwards, President of Kymanox, chose a career in Life Sciences. Evan's passion for improving patients' lives began in childhood alongside his twin brother, Eric. Together they became co-inventors of AUVI-Q epinephrine auto-injector. This early start shaped his journey to becoming a great leader in our industry. In his words: "We have great people, great partners, and our work is important as it impacts patients' lives. While we do face challenges, we are fortunate to be in an industry that makes an impact. We wake up each day because patients deserve better." Evan guides Kymanox clients through complex product development and commercialization challenges, turning cutting-edge ideas into life-changing realities for patients. Partner with Kymanox to work with some of the brightest minds in this arena. What drives your commitment to life sciences? Share in the comments or follow us for more inspiring Kymanox team stories. Subscribe: https://lnkd.in/eYDXYarv Follow Kymanox: https://lnkd.in/e35y_dQq Get in Touch: kymanox.com