R&D Head- Plasma Fractionation

Ahmedabad, Gujarat
Permanent
Full-time

6 days ago
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We are seeking an experienced R&D Head to lead research and product development activities for the Plasma Fractionation Division. The ideal candidate will have a strong background in plasma protein separation, product development (IVIG, Albumin, and Coagulation Factors), viral inactivation technologies, and regulatory-compliant innovation. The role involves end-to-end ownership of pipeline development, technology transfer, and scientific leadership.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.

Opportunity to work with a leading Indian pharmaceutical companyOpportunity to drive R&D initiativesQualifications:

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.

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.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.

Michael Page