i-Pharm GxP

The FDA has confirmed that cybersecurity is now an integrated requirement in medical device development, reflected in its updated Quality System Regulation and new Section 524B mandates under the FD&C Act. A few key changes medtech companies should be aware of: 🔐 Cybersecurity is now part of Quality System design controls 🔐 Software Bill of Materials (SBOM) is mandatory for all connected devices 🔐 Submissions must include system architecture and risk mitigation plans 🔐 Independent testing such as code analysis and penetration testing is expected 🔐 Lifecycle patching and vulnerability management must be built in 🔐 Clear labelling is required to help users manage residual risk If you’re working in medical devices or regulatory affairs, these are the key changes you need to know. Swipe through our quick summary to get up to speed. #iPharmGxP #MedicalDevices #CyberSecurity #FDA

Small-batch aseptic manufacturing is becoming a key focus in the production of advanced cell and gene therapies. As demand grows for personalised medicines and high-value biologics, this in turn is driving demand for skilled professionals in: → Aseptic process validation → GMP-compliant fill-finish operations → QA and regulatory compliance At i-Pharm GxP, we work closely with teams building and scaling small-batch capabilities across sterile and biologics manufacturing. If you’re working in this space or looking to move into it, send us a message to learn more. #iPharmGxP #SterileManufacturing #AsepticProcessing

🚨 The Future of Validation is Here: Are We Ready? 🚨 The world of Commissioning, Qualification & Validation (CQV) is changing faster than ever. Regulators aren’t just tweaking the rules, they’re rewriting the playbook. Here is what I’m watching right now: 📊 Data Integrity: Trustworthy, auditable, end-to-end traceability is now non‑negotiable. 🦠 Contamination Control: EU GMP Annex 1 raised the bar, proactive Contamination Control Strategies are the new standard. ⚖️ Quality Risk Management: ICH Q9(R1) demands consistent, science‑based, preventative risk approaches. 🤖 AI Regulation (Annex 22): For the first time, Europe is setting a regulatory framework for AI & machine learning in GMP. AI will be regulated like any other critical process. 📌 The message is clear: Validation is no longer a box‑ticking exercise, it’s a continuous lifecycle, driven by digitalization and global harmonization. For CQV and Validation professionals, this means: New skill sets (digital, risk‑based, AI literacy) Tighter collaboration across global teams Pressure to deliver compliant, future‑proof systems faster than ever 👉 Question for my network: How prepared do you think our industry is for the coming wave of AI‑focused GMP requirements? I’ll keep sharing regulatory shifts that affect Validation professionals across the East Coast & beyond, follow me to stay ahead. #Validation #CQV #Pharma #Annex11 #Annex22 #DataIntegrity #AI #Quality #LifeSciences

Our latest GxP Insights newsletter is out now! This edition explores how smart combination products are transforming drug delivery and the talent shaping that change. Inside: 💉 Growth trends in connected autoinjectors and wearable devices 📊 How companies like BD, Medtronic, and Janssen are adapting to new FDA guidance 🔧 The skills in demand across NJ, MA, and MN, from regulatory affairs to embedded systems If you’d like to receive the newsletter directly to your inbox, drop your email in the comments or DM us to be added to the list. #iPharmGxP #LifeSciences #MedTech #Biotech

🚨 Who’s Building the Future of Pharma? Massive East Coast Expansions Need Construction Managers🚨 Several leading pharmaceutical and biotech firms are investing billions in U.S. manufacturing expansions especially in the East Coast corridor. Want to build impactful projects and shape the future of pharma infrastructure? This is your moment. ✅ Eli Lilly and Company has poured $5.3B into expanding its API facility in Lebanon, Indiana ✅ AstraZeneca committed a $50B U.S. investment through 2030: including a multi‑billion‑dollar drug substance plant in Virginia and cell therapy manufacturing in Rockville, MD ✅ Biogen is injecting $2B into new fill-finish and ASO capabilities across its RTP campuses in North Carolina ✅ Roche is expanding its diagnostics manufacturing in Indianapolis with a $550M investment and continuous glucose monitoring capacity ✅ Merck is building or will build a $1B biologics center in Delaware, plus a nearly $900M expansion of its animal health facility in Kansas ✅ Ongoing projects include Pfizer’s $100M expansion in Sanford, NC, and a $200M biologics build-out in Andover, MA 🎯 Why Construction Managers Need to Engage Now: Massive scale multi-billion-dollar sites built from scratch Cutting-edge facilities aseptic fill-finish, ADCs, cell/ gene therapy lines, API plants 👉 We're on the lookout for Construction / Project Managers to lead these transformative build-outs. If you're experienced in GMP or Large Capital Projects, reach out! 📩 DM me or comment below to explore how we can support you or your peers in securing these roles. #PharmaConstruction #LifeSciences #ValidationJobs #Commissioning #Engineering #ProjectManagement #EastCoastBiotech #FacilitiesBuildout #HiringNow #PharmaHiring

Know someone working in Life Sciences who’s open to a new role? We’re always keen to connect with experienced professionals across biologics, cell and gene therapy, and sterile manufacturing. If you refer someone and we place them successfully, you could earn up to $2,000 in vouchers as a thank you. To make a referral, just send their CV and contact details to: Harry Reeve - https://xmrrwallet.com/cmx.plnkd.in/ec577ec9 Hamish Corson - https://xmrrwallet.com/cmx.plnkd.in/ejFpDt2r Let’s help great people find great opportunities. #Referral #iPharmGxP #LifeSciences

🚨 Big Moves in ADC Manufacturing: Simtra BioPharma Solutions Secures 65 Acres for U.S. Expansion🚨 The ADC boom is here, Simtra BioPharma Solutions is seizing the moment. The CDMO just acquired a 65-acre site in Bloomington, Indiana with plans to expand its fill-finish facility. The project could make Simtra the first CDMO in the U.S. to offer commercial-scale drug product manufacturing of antibody-drug conjugates (ADCs). Why this matters: ✅ ADCs are one of the fastest-growing classes in oncology. ✅ The new site will focus on injectable biologics, with isolator-based vial and prefilled syringe lines. ✅ Comes on the heels of Simtra’s 5-year ADC partnership with Merck KGaA’s MilliporeSigma. ✅ Follows a wave of ADC investments from CARBOGEN AMCIS, Veranova, and Pfizer. With demand for ADC capacity skyrocketing, Simtra’s move could redefine U.S.-based commercial ADC production. 👉 Do you think Indiana could become the next major hub for ADC manufacturing? 🔔 I post weekly pharma news and hiring updates across the East Coast. If you work in biotech, validation, or engineering, give me a follow to stay ahead. #Pharma #Biotech #LifeSciences #Manufacturing #ADCs #Oncology #Validation #PharmaceuticalManufacturing #Biopharma #CDMO #DrugDevelopment #GxP

Novo Nordisk has kicked off Phase 3 trials for amycretin, a next-generation obesity treatment that early data suggests could outperform both Wegovy and Zepbound. Why does this matter? → Obesity is one of the fastest-growing therapeutic areas globally → Dual-acting drugs like amycretin could redefine the standard of care → Commercial success here could fuel even greater investment into biologics manufacturing and aseptic fill-finish capabilities With major players like Novo Nordisk, Eli Lilly and Company and Pfizer ramping up capacity, demand for regulatory, validation, and quality expertise continues to grow particularly across East Coast hubs. If you're hiring or looking for your next opportunity in advanced therapies, we’re here to help. #iPharmGxP #Biologics #AsepticManufacturing #NovoNordisk #Wegovy

🚨 The Biggest Pharma Bet in U.S. History? 🚨 AstraZeneca yesterday announced a $50 billion investment in the United States over the next 5 years and it is headlined by a record-breaking drug manufacturing facility in Virginia. The company is going all-in on U.S.-based production, with expansion plans across: 🏭 Virginia (small molecules, peptides & oligonucleotides) 🧬 Maryland (Gene therapy + R&D) 🔬 Massachusetts (R&D) 💊 Indiana, Texas, and California (Clinical supply & scale-up) The goals? ✅ Hit $80B in global sales by 2030 ✅ Secure 50% of that from the U.S. ✅ Strengthen supply chain resilience and drug accessibility This is just the latest in a string of huge U.S. commitments from big pharma (Johnson & Johnson, Biogen, Roche, Eli Lilly and Company, Novartis, Sanofi...) it cements the U.S. as the global powerhouse for life sciences manufacturing and innovation. Virginia, in particular, is heating up. 🔥 🔔 Life science professionals: validation, engineering, quality, automation, I post weekly major Life Science updates, follow me to stay in the know. 👉 Need CQV or Validation support? I’ve built one of the top consultant networks across the East Coast. Reach out to chat confidentially about how we can help. #LifeSciences #PharmaNews #AstraZeneca #PharmaManufacturing #Validation #EngineeringJobs #GxP #VirginiaBiotech #CQV #PharmaGrowth #PharmaJobs #USManufacturing #BiotechNews #PharmaUSA #GMP #FDA #Biopharma

As advanced therapies continue to scale, the talent market is moving just as fast as the science.  If you're looking to grow your career in biologics, here are four areas seeing consistent demand: → Regulatory Affairs Experience with INDs, BLAs, rolling submissions, and pre-approval meetings  →Validation Engineering Expertise in biologics-specific systems are key to maintaining GMP compliance in sterile environments. → Quality Assurance GMP, QMS, data integrity, and inspection readiness are non-negotiable in high-stakes biologics production. → Clinical Operations & Compliance Strong clinical teams that can manage trial integrity and ensure data quality while staying aligned with regulatory frameworks are critical. Whether you're already in the space or looking to transition in, these areas represent meaningful opportunities for impact and career progression. If you're looking to advance your career in life sciences, we’d love to hear from you. Send us a message to get started. #iPharmGxP #Biologics #LifeSciences #GxPCareers