R&D Head- Plasma Fractionation

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

Skills Required

Elisa, Protein Purification, Gmp, Analytical Methods, Glp, nanofiltration , sds-page, Chromatography