▷ (Apply Now) R&D Head- Plasma Fractionation

4 weeks ago

Ahmedabad India Michael Page Full time

Job Description - 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. / M.Pharm / M.Tech / M.Sc. 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 (e.g., WHO PQ, EMA/USFDA). - Experience in biosimilars or biologics is a plus. What's on Offer This role offers an exciting opportunity to lead cutting-edge innovation in one of India's fastest-growing therapeutic segments. As the R&D Head, the candidate will drive end-to-end product development for life-saving plasma-derived medicines (IVIG, Albumin, Coagulation Factors) and shape the future of plasma therapies. Contact: Sangya Shaily Quote job ref: JN-082025-6823096

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