R&D Head | Plasma Therapy | Pharma | Ahmedabad
2 days ago
Opportunity to work with a leading Indian pharmaceutical company Opportunity to drive R&D initiatives About Our Client Our client is a leading Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, with a strong presence in generics, biosimilars, and specialty medicines across more than 85 countries. Job Description The key responsibilities include: Strategic Leadership & Innovation Define and execute R&D strategies for plasma-derived products in alignment with company objectives. Lead the development of new plasma-derived therapeutics: IVIG, Albumin, Factor VIII/IX, Anti-D, etc. Collaborate with executive leadership on pipeline planning and long-term innovation roadmaps. Process Development & Optimization Drive upstream and downstream process development including plasma fractionation (Cohn method/chromatography). Design and execute virus inactivation/removal validation studies (solvent-detergent, nanofiltration, heat inactivation). Oversee scale-up activities, process robustness studies, and continuous process improvements. Regulatory & Quality Compliance Ensure R&D programs align with national and international regulatory guidelines (CDSCO, WHO, USFDA, EMA). Support dossier preparation, CTD documentation, and respond to regulatory queries for clinical trials or product approval. Technology Transfer & Collaboration Coordinate tech transfer from lab to pilot and commercial scale in collaboration with Manufacturing, QA/QC, and Engineering teams. Liaise with external collaborators, CROs, or academic institutions for co-development or technology sourcing. Team Development & Management Build, mentor, and lead a multidisciplinary R&D team of scientists and process engineers. Manage budgets, lab infrastructure, timelines, and project milestones effectively. The Successful Applicant Qualifications: D. / / / in Biotechnology, Biochemistry, Pharmaceutical Sciences, or related fields. 12-18 years of experience in plasma fractionation R&D, with at least 5 years in a senior leadership role. Proven track record in developing plasma-derived therapies from concept to commercialization. Familiarity with GMP, GLP, WHO-TRS, and biosafety requirements. Strong knowledge of protein purification, chromatography, viral safety, and analytical methods (ELISA, nephelometry, SDS-PAGE). Skills & Competencies: Strategic thinking with scientific depth Cross-functional leadership Regulatory and documentation acumen Analytical and problem-solving mindset Effective communication and project management Preferred Experience: Exposure to international regulatory filings (, WHO PQ, EMA/USFDA). Experience in biosimilars or biologics is a plus.
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Ahmedabad, India Michael Page Full timeOpportunity to work with a leading Indian pharmaceutical companyOpportunity to drive R&D initiativesAbout Our ClientOur client is a leading Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, with a strong presence in generics, biosimilars, and specialty medicines across more than 85 countries.Job DescriptionThe key...
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