Dhiraj Kumar Chopra

About Dhiraj Kumar Chopra

Pharmaceutical Research and Development professional with around 30 years of rich experience in Pharmaceutical Industry, primarily focusing on Generic Product Development of various dosage forms including Sterile, Oral Solid Dosage forms, Generics, Speciality, Branded Generics, 505 B2 for regulated markets(primarily US market), including Novel Drug Delivery Systems (NDDS), with particular skills in terms of • Injections, including Biodegradable Polymer Based Depot Injections/Microspheres/Implants/ Suspensions/Emulsions/Liposomes/Nanoparticles/Colloids etc• Ophthalmics/Otics, including Nanosuspensions/Emulsions/Gels etc• Proteins/Peptides, Antibiotics, Steroids, Hormones based formulations• Sterile Dosage Forms including Liquid Injections in Vial/PFS/Cartridges/Infusion Bags • Customized Packaging Development for Novel Drug Delivery Systems• In-vitro drug release models development for Particulate Drug Delivery Systems (real time as well as accelerated drug release models)• Process Scale Up from Lab Scale to Pilot scale and finally to Commercial Scale• Aseptic Processing/Terminal Sterilization/Filtration/Gamma Irradiation/ETO etc• QbD/DoE/Six Sigma• Regulatory submissions• Project Management• New Product Lead Identification/Selection based upon Technical/Business/Regulatory/ IP/Financial orientations. • Team Building, Motivation, Mentoring, Coaching, Conflict Management• Leading Team across geographies (US/Europe)/across cross functions/Matrix Organization• Close co-ordination with top management for strategic decision making

Experience

1. Vice President R & d

   Par Health

   Feb 2022 — Present · Navi Mumbai, IN

   Head of R&D India site, Leading R&D for Sterile Injections, Oral Solid Dosage forms, Including Novel Drug Delivery Systems for Generic as well as Speciality/505 B2 Segment. Leading R&D team of scientists comprising of Formulation Development, Analytical Development, Analytical Methods Validation, Packaging Development, Knowledge Transfer, Development Quality Assurance Teams to ensure end to end robust and timely Product Development, Scale up, Regulatory Submissions, Agency Query Responses and Approvals (Focusing on regulated market, primarily US Market). Coordinating across various cross functional team members from Project Management/Regulatory/IP/Engineering/Manufacturing/Quality/Business teams to ensure smooth scale up to plant/ regulatory submissions/ query responses/ product approvals and successful commercialisation of developed products for regulated markets. Collaborating/working closely along with cross functional teams across the globe including Top Management. Leading administration for the R&D site.

Education

• Siksha 'O'​ Anusandhan University

  Doctor of Philosophy (Ph.D.), Pharmacy

  2012 — 2020

• Indira Gandhi National Open University

  M.B.A., Management

  1998 — 2001

• Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)

  B. Pharm., Pharmacy

  1989 — 1993

• Panjab University, Chandigarh

  M.Pharm., Pharmaceutics

  1993 — 1995

Skills

• Validation
• V&V
• Pharmacology
• Pharmaceutics
• Verification and Validation (V&V)
• Glp
• Generic Programming
• Standard Operating Procedure (Sop)
• CRO
• R&D
• Biopharmaceuticals
• Regulatory Affairs
• Lifesciences
• Life Sciences
• High-Performance Liquid Chromatography (Hplc)
• CRO Management
• Technology Transfer
• Hplc
• Polymers
• Formulation
• Pharmaceutical Industry
• Sop
• Chromatography
• Good Laboratory Practice (Glp)
• Drug Delivery
• Biotechnology
• Research and Development (R&D)