R&D Head | Plasma Therapy | Pharma | Ahmedabad

7 days ago

Ahmedabad, India Michael Page Full time

Opportunity 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 responsibilities include: Strategic Leadership & InnovationDefine 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 & OptimizationDrive 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 ComplianceEnsure 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 & CollaborationCoordinate 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 & ManagementBuild, mentor, and lead a multidisciplinary R&D team of scientists and process engineers.Manage budgets, lab infrastructure, timelines, and project milestones effectively.The Successful ApplicantQualifications: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 depthCross-functional leadershipRegulatory and documentation acumenAnalytical and problem-solving mindsetEffective 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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