ANZALP PHARMACEUTICALS PVT LTD

🌍 Consultant – Albumin & Immunoglobulin Manufacturing (Future Director Role) We are looking for an expert in Albumin and Immunoglobulin production to join us as a Consultant , with the opportunity to transition into a full-time Director of Albumin & Immunoglobulin Production as we expand. This is a unique chance to help shape and lead a cutting-edge biologics manufacturing program with long-term impact. 🔬 About the Role As a consultant, you will: Guide us in designing and scaling manufacturing processes for Albumin and Immunoglobulins. Advise on technology selection, facility setup, and equipment procurement . Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines . Support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance. Implement quality assurance and quality control systems . Mentor and train internal teams to build long-term organisational expertise. On successful engagement, you will transition into the Director role , leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division. ✅ What We’re Looking For Advanced degree (M.Sc./PhD in Biotechnology, Biochemistry, or related field). 10+ years’ experience in biologics manufacturing, with specific expertise in Albumin and Immunoglobulins. Proven track record in large-scale plasma fractionation or recombinant protein production . In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO). Strong leadership qualities with the potential to scale into a Director role. 🌟 Bonus Skills Experience engaging with regulatory authorities . Familiarity with intellectual property, licensing, and compliance in biologics. Knowledge of market access and global trade regulations . 📍 Location [on-site/hybrid/remote consulting acceptable initially] 💼 Engagement Terms Phase 1: Consultant (part-time/flexible, project-based). Phase 2: Full-time Director of Albumin & Immunoglobulin Production. 📩 How to Apply If you have the expertise and vision to lead Albumin & Immunoglobulin manufacturing into the future, we’d love to hear from you. 👉 Please send your CV and a short cover note highlighting relevant projects and achievements to: hr@anherb.com