Samir Kulkarni

About Samir Kulkarni

5 years of research and development experience in pharmaceutical drug discovery and development, solid process engineering, solid handling, crystallization, Process development, Project management, polymorph discovery and control, co-crystallization and grinding.• Responsible for project planning and execution, focusing on solid-state research of pharmaceutical compounds.• Good experience working with small quantity of API’s and High-throughput experimental platforms. • Hands on experience with drug substance characterization including crystallinity assessment, solubility determination, and physicochemical stability evaluation with various lab equipment including LCMS, GC, NMR, FTIR, Raman, TGMS, TGA, XRPD, DSC, SEM, TEM, Malvern, Dissolution apparatus and DVS.• Part of pharmaceutical formulation development team and responsible for finding new alternative route of administration for poorly water-soluble drugs.• Good experience with impurity analysis and purification of API’s.• Responsible for planning and implementation of the Chemical process to obtain the most stable solid form of an API.• Responsible for development of new analytical methods required during the quantification of API’s. • Carried out the identification of new targets from the existing marketed drug within the pharmaceutical development group. • Directly responsible for implementing the newly self-invented fluidized bed used in the pre-formulation studies of API’s.• Good exposure & expertise in the area of crystallization and separation along with operation and troubleshooting of process equipment’s.• Actively participated making business case documents for new target molecules and presenting them in front of management team.• Good experience of supervising lab experiments. Successfully supervised more than 10 Master student’s during my PhD. • Well trained with c’GMP/GLP practices.

Experience

1. Director of Engineering

   Eli Lilly and Company

   Jun 2024 — Present · Indianapolis, IN, US

Education

• Delft University of Technology

  Doctor of Philosophy (Ph.D.), Crystallization

  2010 — 2014

• KENDRIYA VIDYALAYA, AURANGABAD

  High School

  1986 — 1997

• FH Münster

  Master's Degree, Masters in Applied Chemistry

  2005 — 2008

• S. B. College of Science, Aurangabad, India

  Higher Secondary Education, Science

  1997 — 1999

• Dr. BAMU Aurangabad

  Bachelor's Degree, Pharmaceutical and fine chemicals technology

  1999 — 2003