Raj

CMC Development and Biomanufacturing Executive

Summary

Rajesh is a seasoned executive and consultant with over 20 years of experience in CMC development, manufacturing sciences, and technical operations for drug substances and products. He excels at partnering with leadership teams to streamline development timelines from preclinical stages to commercial approvals, delivering results under accelerated timelines.

Core Expertise

  • CMC Development 
  • Tech Transfer 
  • Biomanufacturing 
  • OPEX Reduction  
  • Patent Filing 

Career Highlights

  • VP PD & CMC: Established development and CMC teams, led CDMO evaluations and tech transfers, and contributed to IND/IMPD submissions and fundraising strategies. 
  • Head of Biomanufacturing: Developed a mammalian R&D project pipeline with significant OPEX reductions, established a PAT group, and filed three patents. 
  • Director, MSAT: Managed a 50-member team, achieved a 95% right-first-time tech transfer success rate, and led the transfer of 30 products resulting in seven successful regulatory approvals. 

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