Joe Link
East Hanover, New Jersey, United States
928 followers
500+ connections
928 followers
500+ connections
About
Senior Quality associate with extensive experience managning tranformational change in a…
Activity
928 followers
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Joe Link reposted thisJoe Link reposted thisToday we unveiled our proposed name change to BeOne Medicines Ltd. Reaffirming our mission to unite the global community against cancer. Read the press release for full details: https://bit.ly/48Oxfyg
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Joe Link shared thisBeiGene is Hiring for some important QA Roles! Very impressive brand new biotech facility!Joe Link shared thisI’m #hiring. Know anyone who might be interested?
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Joe Link shared thisAwesome milestone achieved for BeiGene!BeiGene debuts $800M biologics plant set to create 'hundreds' of jobs in New JerseyBeiGene debuts $800M biologics plant set to create 'hundreds' of jobs in New Jersey
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Joe Link shared thisI’m #hiring. Know anyone who might be interested?
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Joe Link shared thisBeiGene completed steel work at new Biotech Facility in Hopewell NJ
Joe Link commented on a post
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Congratulations! 🎉
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Joe Link liked thisI was in my happy place tonight talking about various ways to strengthen Quality Culture and some of the pitfalls. Huge thank you to Dr. Elizabeth Gilbert for the wonderful presentation; Beyond CAPA: Closing the Quality-Culture Gap in Regulated Industries! I always appreciate my ASQ Raleigh Section and our amazing Special Interest Group (SIG) meetings. Fang X Zhou, PhD, Whitney G. Touch, Tim Whetten
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Joe Link liked thisJoe Link liked thisCalculating the human starting dose is often treated like a math problem ✅ 𝗜𝘁 𝗶𝘀𝗻’𝘁. NOAEL, HNSTD/STD₁₀, and MABEL can all be calculated correctly, and still lead to very different starting doses. That doesn’t mean one method is “right” and the others are “wrong.” It means they answer different 𝘳𝘪𝘴𝘬 questions. → 𝗡𝗢𝗔𝗘𝗟 approaches emphasize historical extrapolations → 𝗛𝗡𝗦𝗧𝗗 𝗼𝗿 𝗦𝗧𝗗₁₀ methods shift how conservatism is applied → 𝗠𝗔𝗕𝗘𝗟 forces earlier integration of PD and translational relevance I see INDs stumble not because the starting dose was indefensible, but because the reasoning behind it was never clearly articulated. The formula matters, sure. But the 𝘳𝘢𝘵𝘪𝘰𝘯𝘢𝘭𝘦 matters more. If your bridge from nonclinical to clinical doesn't align, your IND will fall through faster than the reviewers can follow the logic. 📌 𝘐𝘧 𝘺𝘰𝘶 𝘯𝘦𝘦𝘥 𝘩𝘦𝘭𝘱 𝘥𝘦𝘤𝘪𝘱𝘩𝘦𝘳𝘪𝘯𝘨 𝘺𝘰𝘶𝘳 𝘩𝘶𝘮𝘢𝘯 𝘴𝘵𝘢𝘳𝘵𝘪𝘯𝘨 𝘥𝘰𝘴𝘦, 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘮𝘦. #toxicology #nonclinicaldevelopment #nonclinical #regulatory #ind #drugdevelopment #biotech
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Education
Languages
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German
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