Dr Munish Dhiman

I am a Formulation Scientist with a Ph.D. in Pharmaceutics and nearly 20 years of industrial experience in formulation development and technology transfer of solid oral, liquid oral, injectable dosage forms for regulated markets, including the USA, Europe, Australia, and Canada.

Over the course of my career, I have worked with leading pharmaceutical organizations: Dr. Reddy’s Laboratories, Glenmark Generics Ltd, Ipca Laboratories Ltd, Jubilant Generics Ltd, Umedica Laboratories Ltd and ACI Healthcare Ltd. My expertise encompasses formulation and process development, technology transfer, scale-up, process validation, reformulation, life cycle management, market extension, project management and third-party manufacturing management.

I have extensive experience in leading scale-up and technology transfer activities, implementing Quality by Design (QbD) principles, establishing critical process parameters and control strategies, optimizing manufacturing processes, and addressing regulatory queries, including Information Requests (IRs), Discipline Review Letters (DRLs), and Complete Response Letters (CRLs).

I recently came across a circular regarding an opening in R&D requiring experience in the US and EU markets. I am enthusiastic about the opportunity to contribute my technical expertise and industry experience toward the continued growth and success of your organization.

I have attached my resume for your kind consideration and would welcome the opportunity to discuss how my background aligns with your requirements.

Thank you for your time and consideration. I look forward to hearing from you.

Sr General Manager and Head-R&D at ACI Healthcare and Pharma Limited (2023-08 – Present)

Overall responsibility of Formulation development, technology transfer and Analytical departments. Dosage forms - OSD, DPI, MDI, Injections, Oncology products.

• Key result areas: Formulation development and tech transfer: OSD, Oral liquids, Injectables, DPI and MDI.
• Leading the R & D setup for Oncology & biotech (Injections and OSD's) including R & D design, equipment finalization, facility updation in line with safety and containment requirements as per current regulatory requirements.
• Solubility and bioavailability improvement
• Stability enhancement and reformulation of old problematic formulations
• Innovative product development and launch

GM & Head, Formulation Research and Development at Umedica Labs (2021-09 – 2023-08)

Handling team of 23 Scientists. Formulation & development of stable, pharmaceutically and bioequivalent non-infringing/innovative new product based on QBD Approach. Technology transfer of products from R&D lab to site (Pilot scale).

• To lead prototype development, bioequivalence study, scale up activities, Technology Transfers, based on QBD at in-house pilot plant which includes data interpretation and establishing in vitro and in vivo correlation and critical process parameters along with control strategies
• To perform prototype development, technical evaluation and suitability of site transfer for Jubilant products and In-licensing projects.
• To co-ordinate for preparation of Technology Transfer Documents & successful Technology Transfer.
• Product screening, feasibility evaluation and technical assessment and budget preparation.
• Development of alternate vendors for API's and Excipients. Cost saving idea generation for process/ formulation and implementation at site. Reformulation and troubleshooting of commercial products.
• Product development, Technology transfer/Scale up/Exhibit batches done for more than 80 products at Pilot/commercial scale (oral dosage forms of IR /MR type/Injections).
• Filed 2 FTF (NCE-1) product for US market: Successfully developed and filed ANDA for two NCE-1 products in Year 2013 & 2019.
• Filed more than 70 products for regulated market like USA, EU, AUS (Solid oral dosage forms of IR /MR delivery/injectable and powder for suspension oral dosage form)
• ROW extension products ~40 ROW filings in past 5 years.
• Life Cycle Management: Successfully implemented alternate source of API's and excipients in commercial products for cost saving/de-risking purpose. Process improvement/Reformulation done and change implemented at manufacturing site for more than 80 products.
• Developed critical products: Pellets/MUPS/Extrusion-spheronization/POS/ DR POS/Sachets for key molecules.
• Good experience on complex generic products.
• To provide technical support to manufacturing site for OOS/ OOT investigations & to Drug regulatory affair for regulatory queries.
• Regulatory support for deficiency response received from regulatory agencies
• Co-ordinate with different stakeholders like SCM, IP, DRA, QA, QC, Production, ARD & F&D for smooth operation.
• Involved in day-to-day analytical planning for effective resource utilization with an aim to maximize the efficiency.
• Life Cycle Management: Successfully implemented alternate source of API's and excipients in commercial products for cost saving/de-risking purpose.
• Process improvement/Reformulation done and change implemented at manufacturing site for 7 products. Developed Critical DR Tab/ Pellets/MUPS/POS (Powder for Oral solution), Matrix Formulations/immediate release formulation/Processes for key molecules.
• To prepare, track and communicate the project timeline and progress with internal & external customers.
• Successful filing done for 15 products for US/EU market in ~2 years without facing major challenges and regulatory queries.
• Successful development of 18 New Product Development (NPD's) ready for scale up and technology transfer to the site.
• Alternate vendor developments (AVD) / New ROS switch of 2 API's leading to major cost savings.
• AVD of major 30+ excipients leading to major cost savings.

Associate Director - Formulation R & D at Jubilant Generics Ltd (2017-06 – 2021-09)

Promoted from Sr GL to Associate Director on July 1st, 2020. Handling team of 8 Scientists. Dosage forms-OSD (IR/MR).

• Successful filing done for 10 products non-infringing/innovative for US/EU market without facing major challenges and regulatory queries.
• Successful development of 8 New Product Development (NPD's) [non infringing/innovative] which are ready for scale up and technology transfer to the site.
• Experience on development of products with Controlled Substance and Low dose active components
• AVD/ New ROS switch of 4 API's & 14 excipients leading to major cost savings.
• Coordination with external CDMO for exhibit batches mfg in USA.

Sr. Manager in R& D (F) at IPCA Labs Ltd. (2015-03 – 2017-05)

Dosage forms-OSD (IR/MR).

Research Scientist in R & D (NDDS) at Glenmark Generics Ltd (2012-07 – 2015-02)

Dosage forms-OSD (IR/MR), Injections.

Deputy Manager in R & D (CPS-Formulations) at Dr Reddy's Laboratories Ltd. (2008-03 – 2012-06)

Promoted from Asst Manager to Deputy Manager 1st Oct, 2010. Dosage forms-OSD (IR/MR)

Research Associate in R& D (F) at IPCA Labs Ltd. (2003-08 – 2004-08)

PGDBM in Business Management – NMIMS (2022 – 2022)

Ph.D. in Pharmaceutics – The M.S. University of Baroda (2003 – 2008)

Master of Pharmaceutical Science in Pharmaceutics – K.M.Kundnani College of Pharmacy (2001 – 2003)

B. Pharmacy in Pharmacy – R.C. Patel Pharmacy College (1998 – 2001)

Class XII in General Education – Govt. Senior Secondary School (1996 – 1997)

Class X in General Education – Adarsh Shishu High School (1994 – 1995)