Dhakshnamoorthy V
Iowa City,IA
Summary
Strategic and innovation-driven Pharmaceutical Scientist with over 14 years of global experience in oral and parenteral drug product development across leading pharmaceutical organizations and CDMO environments. Demonstrated leadership in end-to-end NDA/ANDA development for USFDA, EMA, and semi-regulated markets. Proven expertise in oral peptide and small molecule formulation, pre-formulation, advanced drug delivery technologies, CDMO oversight, technology transfer, and clinical supply chain management. Adept in regulatory strategy and documentation for global submissions with a strong focus on quality, compliance, and efficiency.
Overview
15
15
years of professional experience
Work History
Formulation Scientist
UI Pharmaceuticals
Iowa City, USA
07.2021 - Current
- Company Overview: University of Iowa
- Developing parenteral formulations for NCE molecules under CDMO model.
- Working on lyophilized, high-viscosity, and fill-finish sterile injectables.
- Supporting oral solid dosage formulation development across clinical stages.
- Managing projects from early-stage development through GMP-scale manufacturing.
- University of Iowa
Senior Scientist (Formulation Development)
GSK Pharmaceuticals
Suzhou, China
07.2021 - 06.2024
- Company Overview: Suzhou, China
- Developed 6 solid oral products including IR/SR tablets, pellets, sachets, and soft gels.
- Technical SME for risk scoring, scale-up gap analysis, DoE, and process mapping.
- Managed documentation, SOPs, experimental records, and stage-gate protocols.
- Suzhou, China
Group Leader (FR&D)
Jingfeng Pharmaceuticals
Shanghai, China
07.2019 - 05.2021
- Company Overview: Shanghai, China
- Led team for solid oral dosage development; set up OSD lab and pilot facility.
- Executed 3 complex USFDA generics: osmotic coating, roller compaction, Wurster pellets.
- Audited BE centers and coordinated BE studies across India and China.
- Shanghai, China
Senior Executive (Formulation Development)
Pharmaniaga Research Centre
Shah Alam, Malaysia
08.2016 - 05.2019
- Company Overview: Shah Alam, Malaysia
- Developed 8+ oral formulations, including SR tablets, DR pellets, and low-dose IR tablets.
- Applied hot melt granulation and patent strategies for BCS Class II/IV compounds.
- Shah Alam, Malaysia
Senior Scientist
Biocon Research Limited
Bangalore, India
09.2014 - 07.2016
- Company Overview: Bangalore, India
- Established potent and anti-cancer lab and pilot facility.
- Developed low-dose immunosuppressants and fixed-dose combinations with BE challenges.
- Bangalore, India
Senior Executive
Orchid Research Center
Chennai, India
07.2010 - 09.2014
- Company Overview: Chennai, India
- Developed 8+ formulations for USFDA/EMA with successful BE outcomes.
- Implemented strategies like para IV filings, taste masking, and DR for unstable APIs.
- Chennai, India
Education
M.Pharm - Pharmaceutical Sciences
Tamil Nadu Dr. MGR Medical University
Chennai, India03.2010
B.Pharm - Pharmacy
Tamil Nadu Dr. MGR Medical University
Chennai, India03.2007
Skills
- Formulation development
- Bioequivalence
- Oral solid dosage forms
- Bilayer tablets
- Solid dispersions
- Nano-milled systems
- IR/MR tablets
- Capsules
- Lyophilized injectables
- Device-integrated parenterals
- Pre-formulation
- Solubility
- Compatibility
- Degradation
- HPLC method development
- PXRD
- DSC
- TGA
- Micromeritics
- Particle size
- Nano milling
- Surface area (BET)
- Porosity
- Density
- Flowability
- High/low shear granulation
- Dry granulation
- Spray drying
- HME
- Pelletization
- Wurster coating
- Dissolution method development
- Technical documentation
- ICH-compliant records
- Leadership
- Cross-functional collaboration
- Project management
- QbD-based development
- RLD deconstruction
- API characterization
- Control strategy design
- Audit support
- FDA standards
- EMA standards
- Communication skills
- Presentation skills
- FMEA
- MS Office
- Literature databases
- Lyophilization processes
- GMP compliance
- DoE methodology
- Documentation management
- Risk assessment
- Technical writing
- Problem solving
- Regulatory compliance
- Data analysis
- Process mapping
- Scientific presentation
- Process optimization
- Experiment design
Publications
Exploring the potential of gastro-retentive drug delivery systems: An insightful perspective., Mishra RT, Shukla P, Chumbhale DS, Vellingiri D..., Int J Pharm Investig., 2025, 15, 3, 1-22
Languages
English, Proficient (C2)
Timeline
Formulation Scientist
UI Pharmaceuticals
07.2021 - Current
Senior Scientist (Formulation Development)
GSK Pharmaceuticals
07.2021 - 06.2024
Group Leader (FR&D)
Jingfeng Pharmaceuticals
07.2019 - 05.2021
Senior Executive (Formulation Development)
Pharmaniaga Research Centre
08.2016 - 05.2019
Senior Scientist
Biocon Research Limited
09.2014 - 07.2016
Senior Executive
Orchid Research Center
07.2010 - 09.2014
M.Pharm - Pharmaceutical Sciences
Tamil Nadu Dr. MGR Medical University
B.Pharm - Pharmacy
Tamil Nadu Dr. MGR Medical University
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