Yogesh Bhide Email & Phone Number

Mumbai, Mh, In

Mumbai Area, India

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Leading Cross-Functional Product Development Team: Spearheading a dynamic cross-functional team comprised of members from Supply Chain, R&D, and Marketing/Business Development, reporting directly to the Managing Director.❖ Driving Innovation in Formulation Development: Taking charge of developing innovative formulations for multiple markets and diverse dosage forms, overseeing a dedicated team of 9 associates to ensure strategic product identification and development. ❖ Advancing Extended Release Formulation: Developing a sophisticated extended-release formulation, progressing it to submission Bioequivalence (BE) study status with a streamlined approach that minimizes the need for extensive pilot BE studies. ❖ Ensuring Quality and Technology Due Diligence: Overseeing the quality and technology due diligence processes for contract manufacturing locations, managing a team of three associates to ensure seamless technology transfers and site qualifications. ❖ Managing Quality and Regulatory Responsibilities: Taking on the pivotal role of handling quality complaints and regulatory responsibilities related to both development and market complaints, ensuring adherence to the highest industry standards. ❖ Formulation Development for Key Markets: Playing a crucial role in the formulation development specifically tailored for the pharmaceutical markets in India and Africa, aligning strategies with regional requirements. ❖ Regulatory Interaction and Compliance: Actively engaging with Regulatory Affairs to address queries and ensure compliance, fostering close collaboration to navigate regulatory landscapes effectively. ❖ Coordination with Clinical Services: Coordinating seamlessly with the Clinical Services department for the submission of new drug formulations in the Indian market, ensuring alignment with regulatory and clinical requirements. Driving

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Driving Intellectual Property Initiatives: Demonstrating a commitment to innovation by consistently filing two patents per year, focusing on both process improvements and novel formulations with the Indian Patent Office. ❖ Conducting Technical Audits and Ensuring Regulatory Compliance: Taking charge of technical audits for contract manufacturing locations, facilitating new product introductions, and shouldering the responsibility for regulatory compliances and addressing queries from Indian Regulatory Authorities.

India

Leading a team of scientists for pharma as well as oral care formulations. technology transfers, site technical due diligence for new manufacturing locations. on case to case basis, I am in ok ex in addressing regulatory queries and market feedback for India and ROW markets

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Technical Due Diligence for Manufacturing Site Selection: Conducted comprehensive technical due diligence to assess and evaluate potential manufacturing sites for the interstice transfer of newly acquired Over-the-Counter (OTC) products within the Johnson & Johnson group. ❖ Coordination for Formulation Development and Localization: Spearheaded the coordination efforts for formulation development, playing a pivotal role in the localization exercise for acquired OTC products. Ensured seamless integration and adaptation of formulations to align with India's market requirements. ❖ Single Point Contact for India-Specific Technical Inputs: Assumed the crucial responsibility of being the single point of contact within the Johnson & Johnson Group for India-specific technical inputs related to Oral and External Care OTC products. Facilitated streamlined communication and collaboration among various stakeholders. ❖ Handling of Diverse OTC Products: Managed the technical intricacies associated with a diverse range of OTC products, including mouthwashes with critical volatiles, nicotine chewing gums and lozenges, cough syrups, and baby care topical products, ensuring meticulous attention to detail and compliance with regulatory standards. ❖ Coordination of Material and Process Inputs: Orchestrated the coordination of material and process inputs for Oral and External Care OTC products, fostering a cohesive approach and serving as a key liaison point for technical considerations within the Johnson & Johnson Group. ❖ Quality Assurance for Critical Volatiles in Mouthwashes: Ensured stringent quality assurance measures for mouthwashes with critical volatiles, guaranteeing product integrity and compliance with industry standards. ❖ Specialized Nicotine Chewing Gums and Lozenges Handling: Managed the technical intricacies of specialized products, such as nicotine chewing gums and lozenges, navigating unique formulation challenges.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Cross-Functional Coordination and Technology Transfer: Orchestrated seamless collaboration between Manufacturing (Internal and External), Regulatory Affairs, Supply Chain, and Marketing teams for effective coordination. ❖ Regulatory Affairs Support and Techno-Legal Coordination: Provided crucial support to both External and Internal Regulatory Affairs functions, particularly focusing on techno-legal aspects. Coordinated closely with legal considerations during technology transfers and ensured compliance with regulatory requirements. ❖ Manufacturing Schedule Planning: Worked intricately on the manufacturing schedules during the initial stages of technology transfer, ensuring optimal planning and execution in collaboration with Manufacturing teams. ❖ Collaboration with Marketing for Product Development: Coordinated with the Marketing Department, actively contributing insights into product development attributes. Ensured alignment between formulation capabilities and marketing strategies for enhanced product positioning. ❖ Quality Oversight for Bilayer Antidiabetic Tablets: Provided vigilant oversight and leadership in the development of Bilayer Antidiabetic Tablets, ensuring adherence to rigorous quality standards across all stages of product development.❖ Innovation in Ophthalmic and Injectable Products: Spearheaded the development of innovative Ophthalmic and Injectable products tailored specifically for the US and European markets. Demonstrated a deep understanding of market requirements and regulatory standards in these regions. ❖ Proactive Product Redevelopment Initiatives: Took proactive initiatives based on insights from the Supply Chain and Marketing Departments. Successfully redeveloped existing products to either add value or reduce costs, achieved through strategic alterations in manufacturing processes or formulas while preserving the established brand image.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Formulation Development Leadership: Led the development of both conventional and modified release oral products, showcasing expertise in formulating pharmaceuticals for optimal therapeutic outcomes. ❖ Specialized Delivery Products Innovation: Innovated in the development of specialized delivery products, notably CFC Free Nasal Sprays, contributing to advancements in drug delivery technology. ❖ Coordination for Technology Transfer and Exhibit Batches: Coordinated the seamless technology transfer for new products targeted at the domestic market. Managed exhibit batch manufacturing coordination for other markets, ensuring consistency and compliance with quality standards. ❖ Production Troubleshooting Expertise: Proactively addressed production-level challenges, troubleshooting issues to ensure smooth operations and minimize disruptions in the manufacturing process. ❖ Strategic Cost Reduction Initiatives: Spearheaded strategic cost reduction exercises for existing products, conducting thorough analyses on a case-by-case basis to enhance cost-effectiveness without compromising product quality. ❖ Market Diversification in Product Development: Led product development initiatives for markets beyond the US and Europe, demonstrating adaptability to diverse regulatory requirements and market dynamics. ❖ Contribution to Anti Tuberculosis Product Development: Actively participated in the development of Anti Tuberculosis products for the World Health Organization (WHO), contributing to the SSCC Initiative aimed at reducing treatment duration through changes in antibiotics during the Intensive Phase. ❖ Coordination for Global Product Registration: Coordinated with Manufacturing and Regulatory Affairs teams to facilitate the registration of products in various countries, ensuring compliance with regulatory standards and market entry.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – Process Validations, technology Transfer, Worked as Department Head ❖ Co ordination of technology transfer activities and Process validation for new products.❖ Trouble shooting at production Level.❖ Preparation of routine review of Master Formula Documents❖ New source evaluation of actives and excipients.❖ Process improvement and cost reduction exercises. ❖Implementation of Technologies of GSK UK.❖ Development of formulations for Domestic Market Which includes: Tablets, Capsules, Topical Products and Inhalation Capsules.❖ Production Scale Up activities at Toll Locations.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ To perform Preformulating Studies for oral and parenteral.❖ Formulation development activities involving: - Development of Tablets for Human and Veterinary purposes. - Development of Capsule Formulations - Development of Injectable's for Human and Veterinary purposes. - Conducting Stability Studies as desired.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 – ❖ Preformulating Studies for Topical Products Development.❖ Development and Technology Transfer of Topical Products which includes: - Development of Creams, Ointments, Gels and Lotions. - Involved in Scale up and technology Transfer Activities of Technical Collaboration Products of Foreign Companies. (Products involved were: Erythromycin Gel, Coal Tar and Salicylic Acid Scalp Application)

Doctorate In Pharmaceutical Sciences (Pursuing)

M.B.A.

M Pharm, Pharmacy

Activities and Societies: Life member of Iidian Pharmaceutical AssocoationGraduate and POst graduate from NDMVP Samaj College.

B. Pharm.

Education record