Leadership Team

Leading the team to accomplish the potential of Shilpa Biologicals.

Leadership Team

The leaders guiding strategy, science, regulatory, people and operations at Shilpa Biologicals.

Dr. Uday Harle, Chief Executive Officer (CEO)

Dr. Uday Harle

Chief Executive Officer (CEO)

Profile

Dr. Harle brings nearly 25 years of experience as a strategic and business development leader, having worked with some of the world’s large pharmaceutical companies. He is committed to enhancing Shilpa Biologicals’ global CDMO capabilities and biopharmaceutical business, and to expanding its business network worldwide.

Dr. Harle brings nearly 25 years of experience as a strategic and business development leader, having worked with some of the world’s large pharmaceutical companies. He is committed to enhancing Shilpa Biologicals’ global CDMO capabilities and biopharmaceutical business, and to expanding its business network worldwide.

Dr. Harle has held key leadership positions, including Global Head at Amneal Pharma USA, Abbott and Ferring, securing many successful BLAs, ANDAs and INDs. He has managed the development of biologics, generics and medical devices, accomplished many successful commercial registrations with the US FDA, EMA, MHRA, Health Canada, ANVISA, CDSCO and COFEPRIS, and contributed to multimillion-dollar global portfolio development.

He holds a PhD in medicine and a postgraduate qualification in business management. He owns many patents, over 40 research publications and platform technologies, is a member of global federations and committees, and is a speaker and chair at global conferences.

Ms. Shriya Khandwe, Vice President – Business & Commercial Head (Global)

Ms. Shriya Khandwe

Vice President – Business & Commercial Head (Global)

Profile

Ms. Shriya Khandwe oversees the Europe and Canada formulations business along with the company’s global biologics portfolio. She holds an M.S. in Pharmacology from NIPER, India, and an MBA from IIM Kozhikode.

Ms. Shriya Khandwe oversees the Europe and Canada formulations business along with the company’s global biologics portfolio. She holds an M.S. in Pharmacology from NIPER, India, and an MBA from IIM Kozhikode.

With a distinguished career spanning leading pharmaceutical and healthcare organisations, including Dr. Reddy’s Laboratories, Sun Pharma and IMS Health, Shriya brings extensive expertise in international business development, strategic partnerships and market expansion. Her leadership plays a pivotal role in strengthening the company’s global footprint and driving sustainable growth across key international markets.

Dr. Puspadhwaja Mall, PhD, MBA, Head – R&D, Operations and Portfolio Management

Dr. Puspadhwaja Mall, PhD, MBA

Head – R&D, Operations and Portfolio Management

Profile

Dr. Puspadhwaja Mall brings 19+ years of experience in the biologics and biosimilars industry, creating and producing a range of biosimilars including monoclonal antibodies, recombinant proteins, nanobodies, and conjugated and pegylated proteins for regulated and RoW markets. He has exceptional expertise in operational excellence, portfolio management and aligning organisational goals with strategic objectives.

Dr. Puspadhwaja Mall brings 19+ years of experience in the biologics and biosimilars industry, creating and producing a range of biosimilars including monoclonal antibodies, recombinant proteins, nanobodies, and conjugated and pegylated proteins for regulated and RoW markets. He has exceptional expertise in operational excellence, portfolio management and aligning organisational goals with strategic objectives.

He holds an M.Phil. and PhD from Berhampur University, Odisha, followed by an MBA from IIM Kozhikode. He has served Intas Pharmaceuticals, Cadila Pharmaceuticals, Anthem Biosciences, Lupin Biotech and Hetero Biopharma in various capacities, and has multiple publications in international journals.

Mr. Balaji Sunkara, Associate Vice President · Head – Regulatory Affairs

Mr. Balaji Sunkara

Associate Vice President · Head – Regulatory Affairs

Profile

Mr. Balaji Sunkara brings 23+ years of global and India regulatory experience in the biotech industry, spanning biosimilars, vaccines, biotherapeutics and generics. He has served at different levels with Intas Pharmaceuticals Limited (Biopharma), Hetero Biopharma Limited, Cadila Healthcare Limited, Bharat Biotech International Limited and Gland Pharma Limited.

Mr. Balaji Sunkara brings 23+ years of global and India regulatory experience in the biotech industry, spanning biosimilars, vaccines, biotherapeutics and generics. He has served at different levels with Intas Pharmaceuticals Limited (Biopharma), Hetero Biopharma Limited, Cadila Healthcare Limited, Bharat Biotech International Limited and Gland Pharma Limited.

He has rich experience in regulatory strategy, regulatory submissions and engaging with clients and regulators across regulated markets (US, EU, UK, Switzerland, Canada, Australia and New Zealand), emerging markets in more than 100 countries (Asia, Africa, MENA, CIS and LATAM regions) and the India market. In previous organisations he secured regulated-market, emerging-market and India-market approvals for different molecules. He holds a postgraduate degree in Chemistry from Acharya Nagarjuna University, Andhra Pradesh, India.

At Shilpa Biologicals, he heads the Regulatory Affairs department and is responsible for complete life-cycle regulatory activities, from product development to product launch and the post-approval stage, across in-house products, in-licensing projects and CDMO projects for their respective markets.

Mr. PV Narasimha Rao, Chief Human Resource Officer (CHRO)

Mr. PV Narasimha Rao

Chief Human Resource Officer (CHRO)

Profile

Mr. PV Narasimha Rao is an alumnus of the Indian Institute of Management Kozhikode and brings over 26 years of expertise gained from his tenure with organisations such as the Indian Navy and the Godrej Group.

Mr. PV Narasimha Rao is an alumnus of the Indian Institute of Management Kozhikode and brings over 26 years of expertise gained from his tenure with organisations such as the Indian Navy and the Godrej Group.

PVN is focused on shaping HR strategies and initiatives that foster a culture of collaboration, innovation and growth within the Shilpa Group. He leverages his expertise and insights to drive organisational objectives forward, ensuring that Shilpa Biologicals continues to attract, retain and develop top talent.

Mr. Bose Vinukonda, Operations Head

Mr. Bose Vinukonda

Operations Head

Profile

Mr. Bose Vinukonda has 20 years of experience in the multi-disciplinary, multi-product environment of the biopharmaceutical industry, across monoclonal antibodies, recombinant therapeutic proteins and vaccines. He has expertise in managing the entire breadth of commercial operations, from procurement to conceptualising profitable production projects, and is adept at enhancing production operations, resource utilisation, productivity and team effort.

Mr. Bose Vinukonda has 20 years of experience in the multi-disciplinary, multi-product environment of the biopharmaceutical industry, across monoclonal antibodies, recombinant therapeutic proteins and vaccines. He has expertise in managing the entire breadth of commercial operations, from procurement to conceptualising profitable production projects, and is adept at enhancing production operations, resource utilisation, productivity and team effort.

He holds a postgraduate degree in Biotechnology and has served at different levels and roles with Kwality Pharmaceuticals Limited, Hetero Biopharma Private Limited, Gen Bio Sciences Private Limited and Brilliant Biopharma Private Limited. As Operations Head at Shilpa Biologicals, Bose leads Production, Engineering & Maintenance, Information Technology and Warehouse.

Heads of Function

The heads of quality, analytics, manufacturing science, engineering, supply and technology who keep every program on time, compliant and in control.

Prasad Kanitkar, General Manager – Quality

Prasad Kanitkar

General Manager – Quality

Quality

Prasad Kanitkar leads Quality at Shilpa Biologicals, a company that stands apart for its strong quality culture, scientific approach and commitment to continuous improvement. Quality is built into every process, every decision and every outcome, rather than inspected in at the end.

Prasad Kanitkar leads Quality at Shilpa Biologicals, a company that stands apart for its strong quality culture, scientific approach and commitment to continuous improvement. Quality is built into every process, every decision and every outcome, rather than inspected in at the end.

A focus on innovation, compliance, operational excellence and patient safety enables Shilpa Biologicals to consistently deliver products that earn the trust of customers and regulators alike. The mission is simple: Quality First and Quality Always.

Quality is our responsibility. Compliance is our culture. Patient safety is our purpose.
Anil Bhusanar, QC Head – Quality Control

Anil Bhusanar

QC Head – Quality Control

Quality Control

Anil Bhusanar heads Quality Control. The QC laboratory plays a critical role in ensuring the quality, safety, purity, potency and consistency of biologic products throughout their lifecycle, providing the analytical testing and scientific support needed to evaluate raw materials, in-process samples, drug substance, drug product, stability samples and other critical materials.

Anil Bhusanar heads Quality Control. The QC laboratory plays a critical role in ensuring the quality, safety, purity, potency and consistency of biologic products throughout their lifecycle, providing the analytical testing and scientific support needed to evaluate raw materials, in-process samples, drug substance, drug product, stability samples and other critical materials.

By generating reliable, scientifically sound analytical data, the laboratory supports manufacturing, process development, quality assurance and regulatory compliance. Its contribution is to ensure that every product meets the required quality standards and specifications, strengthening Shilpa Biologicals’ overall biologics capabilities and its commitment to delivering safe and effective products to patients.

Ravindran Chittibabu, Assistant General Manager – GxP Compliance & Development QA

Ravindran Chittibabu

Assistant General Manager – GxP Compliance & Development QA

GxP Compliance

Ravindran Chittibabu is Assistant General Manager at Shilpa Biologicals, responsible for GxP Compliance and Development Quality Assurance. At Shilpa, compliance comes first, ahead of production.

Ravindran Chittibabu is Assistant General Manager at Shilpa Biologicals, responsible for GxP Compliance and Development Quality Assurance. At Shilpa, compliance comes first, ahead of production.

As a patient-centric organisation, Shilpa Biologicals gives the highest importance to quality and compliance, because every product it makes reaches patients. Ravindran fully embraces this philosophy and works to build it into everything the team does, from development through to large-scale commercial manufacturing.

Every product we make reaches patients, and one of them could be someone close to me.
Suresh Manickam, Microbiological Analytical Functions

Suresh Manickam

Microbiological Analytical Functions

Microbiology

The microbiological analytical functions at Shilpa Biologicals play a critical role in ensuring the quality, safety, identity, purity, potency and consistency of its biologic products.

The microbiological analytical functions at Shilpa Biologicals play a critical role in ensuring the quality, safety, identity, purity, potency and consistency of its biologic products.

The team supports the complex requirements of biologics, including:

  • Microbial limit test, bacterial endotoxin test and sterility test
  • Bioburden testing
  • Environmental monitoring of clean rooms and aseptic areas
  • Water testing and stability studies

Its key strength is the combination of strong scientific expertise, robust analytical capabilities and a quality-focused culture. The focus is not simply on manufacturing a product, but on building capabilities across development, analytical sciences, manufacturing, quality and regulatory compliance.

Dr. Kiran Avadhani, Formulation Head

Dr. Kiran Avadhani

Formulation Head

Formulation

Dr. Kiran Avadhani is Formulation Head at Shilpa Biologicals Pvt Ltd, leading formulation development activities from early-stage development through scale-up, technology transfer and commercialisation.

Dr. Kiran Avadhani is Formulation Head at Shilpa Biologicals Pvt Ltd, leading formulation development activities from early-stage development through scale-up, technology transfer and commercialisation.

Dr. Avadhani brings 18 years of experience across organisations including Ipca Laboratories, Reliance Life Sciences, Biocon and Kashiv Biosciences. This experience spans formulation development, process optimisation, product development and cross-functional collaboration with analytical, manufacturing, quality, regulatory and device teams, along with evaluating and managing CDMO/CMO activities to ensure robust, scalable and compliant manufacturing processes.

Awadhesh Kumar Chauhan, Head – MSAT (Manufacturing Science & Technology)

Awadhesh Kumar Chauhan

Head – MSAT (Manufacturing Science & Technology)

MSAT

Awadhesh Kumar Chauhan heads Manufacturing Science & Technology (MSAT), which is responsible for enabling seamless technology transfer, process scale-up, process validation and continuous process improvement across manufacturing operations.

Awadhesh Kumar Chauhan heads Manufacturing Science & Technology (MSAT), which is responsible for enabling seamless technology transfer, process scale-up, process validation and continuous process improvement across manufacturing operations.

The department provides scientific and technical support to ensure robust, efficient and compliant production of biopharmaceutical products. By collaborating across development, manufacturing, quality and regulatory functions, MSAT drives operational excellence and product lifecycle success.

Bikramjit Roy, General Manager – Project Management

Bikramjit Roy

General Manager – Project Management

Project Management

Bikramjit Roy leads Project Management, the connective hub linking science, technology, operations and business at Shilpa Biologicals. The team governs all programs, in-house and CDMO, end to end, from development and technology transfer through clinical and commercial readiness, keeping timelines, quality, cost and strategy aligned.

Bikramjit Roy leads Project Management, the connective hub linking science, technology, operations and business at Shilpa Biologicals. The team governs all programs, in-house and CDMO, end to end, from development and technology transfer through clinical and commercial readiness, keeping timelines, quality, cost and strategy aligned.

The team also stewards external partnerships, translating partner goals into clear priorities so that every function operates as one. The result is predictability, accountability and speed that turn scientific and manufacturing strengths into successful products and lasting partnerships.

Santosh Kadale, General Manager – Engineering, Maintenance & EHS

Santosh Kadale

General Manager – Engineering, Maintenance & EHS

Engineering & EHS

Santosh Kadale leads Engineering, Maintenance & EHS, which ensures safe, reliable, GMP-compliant and uninterrupted infrastructure and utility support for biologics development and manufacturing.

Santosh Kadale leads Engineering, Maintenance & EHS, which ensures safe, reliable, GMP-compliant and uninterrupted infrastructure and utility support for biologics development and manufacturing.

  • Facility engineering, HVAC, critical utilities, electrical systems and automation
  • Maintenance, projects, energy management and EHS
  • Green energy at approximately 90% utilisation, with water conservation, energy-efficient equipment and utility optimisation to reduce energy consumption and carbon footprint

Through reliability, sustainability, compliance and continuous improvement, Engineering provides the infrastructure backbone for high-quality, sustainable biologics manufacturing.

Siddesh C. Itagi, Deputy General Manager – Procurement

Siddesh C. Itagi

Deputy General Manager – Procurement

Procurement

Siddesh C. Itagi leads Procurement, which serves as a strategic business partner enabling Shilpa Biologicals to achieve its scientific, operational and commercial objectives through efficient procurement and supply chain management.

Siddesh C. Itagi leads Procurement, which serves as a strategic business partner enabling Shilpa Biologicals to achieve its scientific, operational and commercial objectives through efficient procurement and supply chain management.

  • Timely procurement of quality materials, equipment and services
  • Strategic sourcing and supplier relationship management
  • Development and qualification of reliable suppliers
  • Cost optimisation and value creation
  • Regulatory and GMP compliance support
  • Supply chain risk mitigation and business continuity
  • Support for R&D, Manufacturing, QC, Engineering and new product development
  • Enhanced operational efficiency and organisational competitiveness
Chandan Volvoikar, Head – Supply Chain Management (SCM)

Chandan Volvoikar

Head – Supply Chain Management (SCM)

Supply Chain

Chandan Volvoikar is Head of Supply Chain Management (SCM), responsible for warehouse operations, with 26 years of professional experience.

Chandan Volvoikar is Head of Supply Chain Management (SCM), responsible for warehouse operations, with 26 years of professional experience.

The biologics warehouse ensures that the right materials are available at the right time, in the right condition and with complete traceability to support biologics manufacturing. Its responsibility goes beyond storage, safeguarding the integrity, safety and compliance of raw materials, packaging materials, intermediates and finished products throughout their warehouse journey.

For temperature-sensitive biologics, controlled storage, cold-chain management, inventory control and GMP-compliant handling contribute directly to product quality and manufacturing continuity, making the warehouse an important link between supply, manufacturing, quality and the overall biologics value chain.

Sikhamani M, Head – Information Technology

Sikhamani M

Head – Information Technology

Information Technology

Sikhamani leads the Information Technology department at Shilpa Biologicals, where the IT infrastructure is built to support secure, reliable and scalable operations.

Sikhamani leads the Information Technology department at Shilpa Biologicals, where the IT infrastructure is built to support secure, reliable and scalable operations.

Robust systems manage critical data with strong cybersecurity and data-integrity controls, and the technology is designed to scale with increasing operations, users and data as the business grows. This gives teams and global partners a secure, connected and future-ready digital environment.

Our Team

Akhil Kabra, Shilpa Biologicals

Akhil Kabra

Amal Sasidharan, Shilpa Biologicals

Amal Sasidharan

Dr. Veerendra Panuganti, Shilpa Biologicals

Dr. Veerendra Panuganti

Rakesh Kumawat, Shilpa Biologicals

Rakesh Kumawat

T. Vara Prasad, Shilpa Biologicals

T. Vara Prasad

Vinayak Gavandi, Shilpa Biologicals

Vinayak Gavandi

Our people

A focused biologics team, not a split portfolio

Scientists and engineers who work only in biologics. Tell us what your programme needs.