SUDESH B. SHETYE
R&D Director
Summary
Result-driven and visionary R&D Director with 14+ years of progressive experience in pharmaceutical R&D, specializing in end-to-end product development of oral solids, parenteral, inhalers, and ophthalmic formulations. Adept at developing patent non-infringing product, leading cross-functional teams, and delivering compliant, cost-effective solutions aligned with global regulatory standards (FDA, EMA, ICH). Proven success in scaling R&D operations, optimizing processes, and launching 30+ products. Strong strategic thinker with expertise in formulation design, technology transfer, and fostering partnerships to accelerate time-to-market.
Innovative and strategic thinker with strong ability to lead and manage research and development projects. Possesses deep understanding of scientific principles and advanced technical skills, including data analysis and experimental design. Capable of driving impactful results that enhance product quality and performance.
Overview
13
13
years of professional experience
4017
4017
years of post-secondary education
3
3
Certifications
Work History
R&D Director
BIEM ILAC
04.2024 - Current
- Manage managers and provide leadership / mentoring to Formulation Development, Analytical Development
- Providing leadership and direction for developing strategy for the delivery of the projects with technical leaders across FR&D, AR&D, Project Management and Portfolio Management groups, agreeing and taking accountability for the technical strategy within their area of responsibility
- Collaboratively manage and provide technical guidance to CROs and CMOs in research and development of drug products, including R&D and manufacturing schedules at multiple CMOs
- Plan and elaborate on scientifically sound experimental development activities together with the respective R&D team, and lead their operational execution, data interpretations and technical conclusions
- Spearheaded the development of 2 patent non-infringing delivery systems, to be the first generic in the market
- Leverage regulatory and technical knowledge and experience in the development of robust CMC regulatory strategies for programs in accordance with recognized standards
- Present and articulate issues for resolution while applying balanced judgment to drive crisp decision-making
- Cultivate relationships with key partners and stakeholders, including Quality, Local and International Regulatories to ensure alignment on regulatory strategy and serve as a technical resource for complex projects
- Manage R&D budgets, resource allocation, and timelines, ensuring effective alignment with corporate goals
- Establish strong relationships with key internal and external partners through regular technical meetings
- Act as CMC reviewer and SME for formulation and drug product regulatory submissions and agency interactions
- Research & Management included conceptualization and technical feasibility evaluation of project proposals, drawing timelines for approved projects, budgeting for financial year, identifying bottlenecks and identifying solutions, coordination with licensing, sourcing, business, service providers & suppliers for timely delivery
R&D Head
GM Pharma
09.2023 - 03.2024
- Lead the R&D division in developing high-quality generic drugs, overseeing a portfolio of oral solids products in various therapeutic areas
- Directed formulation development for oral solid products with successful development of one non-infringing extended release pellets in capsules product
- Accountable for the strategic development of first line leaders to ensure these leaders are equipped with the right support, tools and competencies in order to effectively leader their team and drive the value stream
Formulation Development Manager
Deva Holding (Devatis)
01.2021 - 08.2023
- Lead R&D strategy for a portfolio of 15+ products across oral solids, injectables, inhalers, and eye drops, ensuring alignment with global regulatory standards
- Spearheaded the development of 4 patent non-infringing products for the US market with successful ANDA submission
- Oversaw successful technology transfers to 4 manufacturing sites, ensuring seamless scale-up and compliance with cGMP
- Provided scientific and technical expertise in the development and tech transfer of various pulmonary dosage forms including, pMDIs, DPIs, nasal sprays, nebules - solutions/suspensions, Oral Solid dosage forms, Opthalmic Products and Parenteral Products for EU, US, TR markets
- Collaborated with regulatory teams for FDA and EMEA submission of 16 products with various dosage forms such as Tablets, Metered dose Inhaler, Eye drops, Sterile Injection, accelerating market entry
- Mentored a team of 16 scientists fostering a culture of innovation and achieving 94% employee retention
- Designed and executed protocols to support the development of Dry Powder Inhaler (DPI) and Metered Dose Inhaler (MDI) products
- Actively participated in design of device for Dry Powder Inhaler (DPI) using design FMEA and evaluating the performance w.r.t
- CQAs of drug product
- Ensured accurate tracking and reporting of project deliverables and milestones by maintaining consistent project documentation and preparing periodic updates for the senior management
- Authored and coordinated CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements
- Coordinated and contributed to responses to agency queries and performed quality review of regulatory CMC submissions
Team Leader- Formulation Development
Deva Holding (Devatis)
01.2016 - 12.2020
- Lead formulation development of oral solid, dry powder inhalers and pMDIs, resulting in 10+ product launches in Turkey and Europe market
- Implemented QbD principles across projects, reducing batch failures by 20% and enhancing process robustness
- Led cross-functional teams (QA, QC, Manufacturing) to resolve critical deviations and ensure on-time regulatory submissions
- Provided technical mentorship to the team of scientists to develop, test and scale-up exceptional formulations of oral solids dry powder inhalers, aerosols and oral solid dosage forms for EU, US and TR market
- Provided the interface support between RD and Manufacturing Operations in order to ensure proper implementation of new products into GMP manufacturing operation
- Assigning activities to the team and planning of trials for timely completion of different stages of development
- Maintaining product development documentation / systems and providing updates to another team members
- Compilation, review and approval of product development protocols and reports
- Trouble shooted and solved problem of product development issues in an efficient manner to keep product development projects to their pre-determined timelines
- Supported and interpreted data information for review and presentation at management meetings
- Evaluated patents and developed non-infringement strategies to develop Paragraph IV products
Research & Development Specialist- Formulation
Deva Holding (Devatis)
12.2014 - 12.2015
- Designed developed and optimized appropriate drug product formulation development, especially in dry powder inhalers, aerosols, sterile dosage forms and oral dosage forms for EU, US and TR market
- Performed scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines
- Planned and contributed to project-related scientific/technical activities such as interpretation of results, critical assessment of data and drawing relevant conclusions
- Authored technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose
- Coordinated with RA for filing ANDAs and addressing deficiencies; provided relevant documents to Regulatory Affairs in a timely manner for ANDA filings and Supplements filing
- Conducted troubleshooting and optimization during the technology transfer phase to CMOs, ensuring seamless product commercialization
Assistant Manager
Dr. Reddys Laboratories
07.2012 - 12.2014
- Developed various oral solids products for both generics and New Chemical Entities (NCEs) from concept to completion leading to regulatory submission
- Developed a sound understanding on the regulatory aspects of drug filing adhering to cGMP, GLP, ICH standards
- Worked on multiple projects simultaneously and supervised technicians in implantation of experiments
- Applied Design of Experiments (DoE) to identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) affecting Critical Attributes (CQA) of the drug product
- Developed drug product using hot-melt extrusion drug/polymer technique to increase solubility and bioavailability
- Reviewed, compiled and interpreted results to identify issues and implemented proper control strategies
- Authored and reviewed formulation development sections of regulatory and technical documents, study reports and technology transfer documents
- Successfully submitted ANDAs for complex oral product and answered all the queries received from USFDA
Research Associate
Unichem Laboratories
07.2012 - 12.2014
- Developed formulation and process of immediate and sustained release tablets and capsules
- Hands-on experience with various drug product unit operations- tablet blending, granulation, fluid bed drying, compression, coating, encapsulation, and final product packaging
- Achieved hands-on experience in pre-formulation, formulation and process development, technology transfer and scale-up activities
- Conducted protocol driven pre-formulation activities- API solubility, drug-excipient compatibility, thermal stability, short - term and long term- term ICH stability
- Developed, transferred and filed a stable, bioequivalent tablet dosage form of highly variable and poorly soluble Antihypertensive agent for Europe market
- Developed, transferred and filed a stable, bioequivalent tablet dosage form of an antiprotozoal agent for US market
- Developed and transferred a bioequivalent fixed dose combination product for Europe market
Education
Master of Pharmaceutical Science -
Goa University
Bachelor of Pharmaceutical Science -
Goa University
Skills
- Pharmaceutical R&D Leadership
- IND, NDA 505 (b)(1), 505 (b) (2), NCE, Para-IV
- DPI and pMDI’s device development
- Design of Experiments and Statistical Analysis using Design Expert and Minitab
- Mentor, Motivator
- Technology transfer/Scale-up operations
- Patent evaluation
- Project Management
- Technical report review & writing
- Oral Solids, Parenteral, Inhalers, & Eye Drops
- Regulatory Compliance (FDA, EMA, ICH)
- Cost Optimization & Budget Management
- Strategic Planning & Portfolio Management
Certification
PMP certification
Timeline
R&D Director
BIEM ILAC
04.2024 - Current
R&D Head
GM Pharma
09.2023 - 03.2024
Formulation Development Manager
Deva Holding (Devatis)
01.2021 - 08.2023
Team Leader- Formulation Development
Deva Holding (Devatis)
01.2016 - 12.2020
Research & Development Specialist- Formulation
Deva Holding (Devatis)
12.2014 - 12.2015
Assistant Manager
Dr. Reddys Laboratories
07.2012 - 12.2014
Research Associate
Unichem Laboratories
07.2012 - 12.2014
Master of Pharmaceutical Science -
Goa University
Bachelor of Pharmaceutical Science -
Goa University