Ashish Makwana

Experience

• 

  Cadila Pharmaceuticals Limited

  May 2010 - Dec 2011

  Research Associate in Formulation and Development

   Formulation development of solid oral dosage forms Resource organization & co-ordination with relevant departments like Analytical development lab. Formulation development activity for Lab scale batches/ Pilot BE batches. Execution of scale-up and exhibit batches.

• 

  Zydus Group

  Dec 2011 - Dec 2023

  Manager – Formulation Development (Lead Formulation Team)

  • Led the formulation R&D team, managing the development of oncology and specialty solid oral dosage forms.• Developed generic formulations for companion animals, an underserved yet high-value segment.• Designed bioequivalence studies, and IVIVC models, and formulated prototypes using QbD and DoE principles.• Successfully led technology transfers and troubleshooting for commercial-scale manufacturing.• Worked extensively on solubility enhancement and pellet formulations.• Authored critical regulatory documents: Product Development Reports, MFCs, BMRs, Specifications, and Scale-up Reports.• Implemented Six Sigma methodologies for process optimization and regulatory compliance.• Conducted FMEA-based risk assessments for formulation and process robustness.• Led cross-functional collaboration with R&D, manufacturing, regulatory, and quality teams to drive successful filings. Show less

• 

  Olpha Global

  Dec 2023 - now

  Head Formulation R&D and Technology Transfer

  • Spearheading NCE-1 development, targeting first-to-file submission for the US market.• Leading the formulation of oncology and complex generics, including nanotechnology-driven drug delivery.• Designed bioequivalence studies, and IVIVC models, and formulated prototypes using QbD and DoE principles.• Overseeing technology transfer, scale-up, and commercial readiness for high-value formulations.• Managing regulatory dossier preparation (CTD, ANDA, MAA) and ensuring compliance with global regulations.• Collaborating with CROs, CMOs to expedite approvals and market access.• Conducting risk assessments and troubleshooting formulation challenges to ensure robust manufacturing.• Key contributor to Olpha’s strategic committee, responsible for identifying, evaluating, and finalizing development sites, clinical research sites, and CMO partnerships to streamline product development and commercialization.• Ensuring rigorous follow-up, decision-making, and adherence to timelines for successful execution of tasks with development partners, CMOs, and clients. Show less