Jay Gopal Meher Email & Phone Number

Hyderabad, Telangana, India

Role OverviewI have joined Ferring Pharmaceuticals' Hyderabad division (FHPDC), as a Scientist CMC Formulations (Manager). This new chapter in my career aligns perfectly with my passion for addressing patient unmet needs through innovative pharmaceutical solutions.Key Responsibilities• Designing and working on 505(b)(2) development programs.• Collaborating on bio and clinical studies.• Leading innovation through novel drug delivery systems and formulation optimization.• Developing and commercializing pharmaceutical products.• Partnering with cross-functional teams and external vendors for manufacturing and research services.• Ensuring efficient procurement and supply chain operations.• Navigating regulatory requirements and intellectual property strategies.• Implementing Quality by Design (QbD) principles.• Mentoring scientists to foster growth and innovation.Selected Project• Developing platform technology-based parenteral products for cancer chemotherapy and hormone therapy.• Focusing on end-to-end product development of novel drug delivery systems (parenteral, oral, topical dosage forms).• Identifying gaps in existing treatments, developing targeted therapies in the new product ideation campaign of company.• Working on Life-cycle management strategies by development of novel therapeutics.

Hyderabad, Telangana, India

Role OverviewLed development of innovative differentiated 505(b)(2) products for nasal, ophthalmic and dermal applications. Successfully handled various stages of product development, from pre-clinical studies to scale-up, while ensuring compliance with regulatory and intellectual property requirements.Key Responsibilities• Develop patient-centric differentiated pharmaceutical products, including sol-gel nasal, nano- suspension ophthalmic formulations, and topical products.• Conduct pre-clinical studies for achieving proof of concept for projects, formulation optimization and manage scale-up processes for 505(b)(2) applications.• Apply Quality by Design (QbD) principles and perform pre-formulation studies, alongside data analysis to support development goals.• Mentor junior scientists and trainees, fostering best practices in formulation development.• Collaborate with cross-functional teams on product development and manage stability studies to ensure product integrity across multiple markets.• Oversee project management activities, ensuring compliance with intellectual property and regulatory requirements while meeting timelines and objectives.Selected Projects• Developed innovative sol-gel based 505(b)(2) nasal product aimed at enhancing patient adherence and efficacy for the Russia and India markets.• Designed and developed nano-suspension based 505(b)(2) ophthalmic formulation for the US, Russia, and India markets.• Led the formulation of a differentiated 505(b)(2) topical product for specific dermatological conditions for the US, India, and Russia markets.

Hyderabad, Telangana, India

Role OverviewDevelopment of innovative pharmaceutical products, including complex topical formulations and novel drug delivery systems. Emphasizes compliance with regulatory and quality systems while collaborating with various teams and external partners to drive successful project outcomes in regulated markets.Key Responsibilities• Develop complex bi-phasic topical products, differentiated 505(b)(2) and ANDA formulations for US market, and new topical products for India market.• Apply Quality by Design (QbD) principles, conduct quality risk assessments, and perform process optimization, root cause analysis, and troubleshooting, patent interpretation and gap identification.• Define Target Product Profiles (TPP) and Quality Target Product Profiles (QTPP), establish clinical and regulatory pathways, manage outsourcing, legal/commercial agreements, controlled correspondences.• Ensure compliance with quality systems, regulatory requirements, and EHS standards, and achieving timely execution and delivery.• Collaborate with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and cross-functional teams (CFTs) to conduct internal reviews and audits, estimate costs and budgets, procure raw materials, establish and maintain laboratory operations.Selected Projects• Developed complex bi-phasic topical product of NCE-1 molecule for treatment of atopic dermatitis for the US market and leveraged it to other regulated markets.• Developed differentiated 505(b)(2) product for atopic dermatitis for US market.• Developed new oral topical product for the treatment of cancer chemotherapy-induced oral mucositis for the India market.• Developed a life cycle management product for gingivitis and periodontitis as a brand architecture product for the India market, leveraging it for other regulatory markets.

Lucknow Area, India

Role OverviewJoined the Pharmaceutics Division at CSIR-Central Drug Research Institute (CDRI), Lucknow, as a CSIR Senior Research Fellow, focusing on the development of novel drug delivery systems. Engaged in research aimed at enhancing the efficacy of hydrophobic drugs for chemotherapy through innovative formulations.Key Responsibilities• Develop novel oral self-emulsifying drug delivery systems (SEDDS) for hydrophobic drugs used in chemotherapy.• Conduct pre-formulation studies and proof of concept to establish the viability of new formulations.• Oversee product development processes, ensuring effective oral delivery of active ingredients.• Perform pre-clinical studies, including anticancer cell culture and anticancer animal studies.• Utilize cancer tumor models to assess the efficacy of developed formulations.• Provide training and mentorship to interns, fostering skill development and research capabilities.Project• Developed a novel oral self-emulsifying drug delivery system for a hydrophobic drug aimed at improving chemotherapy outcomes, demonstrating enhanced bioavailability and therapeutic efficacy in pre-clinical studies.

Lucknow Area, India

I joined Pharmaceutics Division, CSIR-Central Drug Research Institute, Lucknow as a Junior Research Fellow in Nov 2012 with Dr Manish K. Chourasia (Senior Scientist). I was working on development of various novel drug delivery systems to enhance therapeutic efficacy of anticancer drug molecules.

Lucknow Area, India

Role OverviewServed as a Research Scholar at the Herbal Medicinal Products Department (HMPD) at CIMAP, Lucknow, focusing on the formulation development and standardization of herbal products and medicines. Engaged in innovative research aimed at creating both conventional and novel drug delivery systems for herbal actives.Key Responsibilities• Develop and standardize semisolid formulations of herbal actives, ensuring consistency and quality in herbal medicines.• Explore innovative approaches to formulation development, enhancing the efficacy and bioavailability of herbal products.• Conduct extensive research to identify optimal delivery systems for herbal actives, balancing traditional methods with modern advancements.• Collaborate with cross-functional teams to integrate findings into practical applications and product development.• Perform stability studies and quality assessments to ensure the integrity of developed formulations.• Provide training and guidance to junior researchers and interns, promoting skill development in herbal formulation techniques.Selected Projects• Developed innovative semisolid formulations for various herbal actives, enhancing their therapeutic potential through optimized delivery systems.• Standardized processes for herbal product formulation, contributing to quality assurance and regulatory compliance in herbal medicines.

Meerut Area, India

Role OverviewJoined the Department of Pharmaceutical Technology at Meerut Institute of Engineering and Technology as a Lecturer, focusing on delivering high-quality education to students in both Bachelor’s and Master’s programs in Pharmaceutical Sciences. Gained valuable experience in academic instruction and student engagement.Key Responsibilities• Teach and develop course materials for undergraduate and postgraduate students in Pharmaceutical Sciences, ensuring alignment with current industry practices.• Facilitate interactive learning experiences through lectures, practical sessions, and workshops, fostering a deep understanding of pharmaceutical concepts.• Assess student performance through examinations, projects, and presentations, providing constructive feedback to promote academic growth.• Collaborate with faculty members to enhance the curriculum and integrate innovative teaching methods.• Mentor and guide students in their academic and career aspirations, encouraging research and participation in extracurricular activities.Selected Projects• Designed and implemented a comprehensive curriculum for pharmaceutical technology courses, focusing on practical applications and industry relevance.• Conducted workshops and seminars to enhance students' knowledge of current trends and innovations in the pharmaceutical field.

Doctor Of Philosophy - Phd, Pharmaceutical Sciences

M.Pharm (Pharmaceutics), Pharmaceutical Sciences, Cgpa 9.59

Bachelor Of Pharmacy - Bpharm, Pharmacy, Cgpa 8.33