Dilip Solanki

A dynamic pharmaceutical leader with over 26 years of extensive experience in Manufacturing Science & Technology, Technology Transfer, Process Optimization, and CRAMS, currently serving as General Manager – MSTG (Formulations) at Sun Pharmaceutical Laboratories Ltd. Recognized for spearheading new product launches, site variations, and large-scale tech transfers across multi-site operations (Paonta Sahib, Baddi, Guwahati), while ensuring regulatory compliance with global authorities such as USFDA, MHRA, and TGA. Proven expertise in Formulation technology transfer, validation strategy, and data-driven decision-making with deep technical command over solid, liquid, semi-solid, and injectable dosage forms.

Adept at transforming pilot-scale concepts into cost-effective commercial realities through meticulous process engineering and strategic leadership. Drives cross-functional excellence in QMS, documentation, EHS, equipment qualification, resource optimization, & market complaint investigation backed by advanced knowledge in tools like SAP, Track wise, and EDMS. A results-oriented visionary committed to innovation, compliance, & operational brilliance in global pharmaceutical manufacturing.

General Manager – Manufacturing Science & Technology Group (MSTG – Formulations) - Sun Pharmaceuticals Laboratories Ltd. - Paonta Sahib, Baddi, Guwahati

(2014-12)

Currently leading the Manufacturing Science & Technology Group (MSTG) for three formulation plants, with responsibility for new product launches, technology and site transfers, process optimization, cost-reduction initiatives, and manufacturing troubleshooting.

• Overseeing pilot scale, test, and exhibit batch executions for a wide range of dosage forms, ensuring robust process feasibility, scalability, and regulatory compliance across all manufacturing sites.
• Championing the formulation development life cycle from lab-scale to commercial production, including batch size optimization, process capability enhancement, and investigation of complex manufacturing challenges.
• Driving cost-efficient manufacturing through strategic process upgrades and continuous improvement projects, with a focus on yield enhancement, resource optimization, and productivity improvement.
• Successfully leading cross-functional teams and coordinating with R&D, QA, QC, RA, supply chain, and production units to ensure timely execution of launches, site variations, and regulatory filings.
• Instrumental in establishing and executing process optimization plans, including risk assessments, control strategy implementation, and compilation of detailed technical reports and process optimization summaries.
• Adept in strategic production planning, ensuring that manufacturing objectives align with business goals while maintaining strict adherence to GMP, regulatory standards, and cost-efficiency metrics.
• Recognized for a hands-on leadership approach in navigating complex technology transfers and ensuring seamless integration of new products into commercial manufacturing platforms.

Deputy General Manager – CRAMS Business - Cadila Pharmaceuticals Ltd. - Ahmedabad, Gujarat

(2011-04 - 2014-12)

Led the CRAMS (Contract Research and Manufacturing Services) vertical, overseeing exhibit batches, site variations, dossier upgrades, validation, and troubleshooting for a diverse range of pharmaceutical formulations.

• Spearheaded technology/process transfer and site variation activities for complex Solid Oral Dosage Forms (Tablets, Capsules, Pellets, Effervescent Tablets), Semi-solids, Sterile/Non-Sterile Liquids, Injectables (Liquid & Lyophilized), and Nutraceuticals tailored for global markets including Europe, the USA, Australia/New Zealand, and South Africa.
• Drove formulation development and technology transfers in collaboration with leading global partners such as Actavis, Sandoz-Novartis, Sanofi-Winthrop, Teva, Taro, and Pliva, ensuring regulatory compliance and market-specific customization.
• Specialized in advanced drug delivery systems including WRAP matrix tablets, bilayer tablets, gastro-retentive systems, osmotic pump formulations, and laser-drilled tablets; hands-on experience with coating technologies like Opadry I/II, Eudragit, Acryl-Eze, and capsule coating solutions.
• Played a pivotal leadership role in "Optimum Utilization of Resources (OURS)" initiatives aimed at enhancing productivity and cost-efficiency across manufacturing operations, in collaboration with Dr. Reddy's Labs and Sun Pharma.
• Supervised end-to-end production planning—from granulation to coating—aligned with SAP-driven market forecasts, ensuring synchronization across departments (PPMC, QC, QA) and optimal plant resource utilization.
• Streamlined documentation and validation procedures, including scheduling and execution of process validations, protocol/report generation, BMR creation, SOPs, online process documentation, shift scheduling, tooling and sieve management, and regulatory compliance records.
• Contributed to facility readiness and successful outcomes in multiple international regulatory audits (TGA, USFDA, MHRA UK, MCA UK, Sanofi UK, Kenya Authority, and others).
• Demonstrated robust exposure to potent and sensitive drug manufacturing (Steroids, Oncological, Immunosuppressants) within Fluidized Bed Processing (FBP) environments, ensuring high standards of safety and quality.
• Proficient with a wide array of manufacturing and testing equipment including RMGs, FBDs, FBP-Glatt systems, capsule filling machines, compression and coating equipment, planetary mixers, roll compactors, and various in-process testing instruments.
• Adept at vendor selection, API/raw material/tooling procurement, and managing Innovator sample handling and solid waste management in compliance with global best practices.

Group Leader, Process Development Lab (PDL) - Ranbaxy Laboratories - Paonta Sahib, Batamandi & Baddi Plants

(2009-08 - 2011-04)

Assistant General Manager, Process Development - Cadila Pharmaceuticals - Ahmedabad

(2008-04 - 2009-07)

Assistant General Manager, Project Coordination & Process Development Lab - Intas Pharmaceuticals Ltd. - Ahmedabad

(2004-04 - 2008-04)

Senior Research Scientist - Astron Research Ltd. (Intas Group – F&D) - Ahmedabad

(2004-04 - 2008-04)

Officer In-Charge - Dr. Reddy's Laboratories - Hyderabad

(2002-10 - 2004-04)

Management Staff - Cipla Ltd.

(2002-08 - 2002-10)

Officer Executive - Intas Pharmaceuticals Ltd. - Ahmedabad

(1999-10 - 2002-08)

M. Pharma - Pharmaceutics & Pharmaceutical Technology - Gujarat University (1999)

B. Pharma - Gujarat University (1997)