R&D Head- Plasma Fractionation

• Opportunity to work with a leading Indian pharmaceutical company
• Opportunity to drive R&D initiatives
  

About Our Client

• 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

Contact: Sangya Shaily

Quote job ref: JN-082025-6823096