Nitin Dhekale

Professional doctorate with 18+ years of experience in analytical research & development and characterization of peptide APIs, drug products, and complex injectable products. Currently associated with Amneal Pharmaceuticals and leading a team of scientists for peptide injectables product characterization and sameness studies. Empathetic leader and ability to motivate the team and perform in fast paced environment.

In-depth understanding of the peptide product cycle from API development, drug product development, characterization and submission strategies.

Assistant General Manager at Amneal Pharmaceuticals (2019-04 – Present)

• Lead a team of scientists to complete characterization activities of peptide APIs, peptide injectables, and complex products and ensure the product readiness as per the USFDA requirements.
• Establish a scientific workflow for the characterization of highly complex peptide APIs and drug products and critical studies of microspheres and nanosuspension products.
• Project planning, weekly and daily work planning for the team and myself and ensuring seamless progress of planned activities.
• Evaluate and adopt modern analytical technologies and design the product-specific characterization strategy.
• Work in collaboration with the peptide synthesis team and the drug product development team during the product development cycle.
• Evaluate and screen the peptide API supplier and review the DMF data.
• Establish the new state-of-the-art facility for characterization studies.
• Provide technical expertise to develop the novel analytical methods for characterization of peptide and complex API and drug products.
• Design the study protocols, method development, method validation, and comparative study reports.
• Transfer analytical methods to the GMP site.
• Lead the telecons with internal stakeholders and contract laboratories and ensure that activities are completed on time.
• Review the analytical data and plan the technical discussions with the team and contract laboratories or institutes.
• Write the scientific report for response to regulatory queries.
• Work in coordination with cross-functional teams: formulation development, validation, QC, RA, QA, and procurement.
• Enhance the team's capabilities with in-house and external training.
• Hire the scientists for team.
• Complete the yearly appraisal for individual scientist and provide the constructive feedback.

Scientist-R1B at Dr. Reddy's Lab. Ltd, IPDO (2018-02 – 2019-04)

Technical Leader at Almac Sciences (2016-11 – 2017-07)

Sr. Executive / Scientist-R1A / Scientist-R1B at Dr. Reddy's Lab. Ltd, IPDO (2009-11 – 2016-10)

Analytical Chemist at Evotec India pvt. Ltd (2008-08 – 2009-11)

Trainee Chemist at Cipla Ltd. (2007-08 – 2008-07)

Ph.D. submission at Dept. of Chemistry, Shivaji University Kolhapur (2017-11 – 2018-01)

Ph.D. in Chemistry – Shivaji University Kolhapur (2011-07 – 2018-02)

M.Sc. in Analytical Chemistry – Shivaji University Kolhapur (2005 – 2007)

B.Sc. in Chemistry – Shivaji University Kolhapur (2002 – 2005)