Essential Qualification

Master's Degree in Biotechnology, Molecular Biology, Cell Biology, Genetic Engineering, Pharmaceutical Biotechnology, Life Sciences, Genomics, Pharmacy (M. Pharm), Regulatory Sciences, or equivalent from a recognized University/Institute.

Essential Experience

Minimum 5 years of post-qualification experience in Cell and Gene Therapy Products (CGT), Advanced Therapy Medicinal Products (ATMPs), biological products,regenerative medicine, stem cell-based products, gene therapy medicinal products, tissue-engineered products, or related areas

Desirable Experience

• Demonstrated expertise in development/ quality assessment/ manufacturing, characterization, regulatory evaluation, or standardization of CGT/ATMP products.

• Experience with regulatory submissions, quality standards, and product evaluation.

• Thorough knowledge of international regulatory and pharmacopoeial requirements including CDSCO, WHO, US FDA, EMA, ICH, USP, European Pharmacopoeia and British Pharmacopoeia

• Experience in drafting pharmacopoeial monographs, general chapters, guidance documents, or regulatory standards.

• Publications in peer-reviewed journals related to CGT/ATMPs.

• Experience in leading scientific committees, expert groups, or multidisciplinary projects.

• Development of quality standards, monographs, and general chapters for Cell and Gene Therapy Products in Indian Pharmacopoeia.

• Provide scientific and regulatory guidance to IPC on CGT/ATMP- related activities.

• Review and harmonize standards with international pharmacopoeias and regulatory agencies.

• Coordinate with national and international experts, regulatory agencies, academia, and industry stakeholders.

• Facilitate training programs, workshops, and expert consultations on CGT products.

• Identify emerging technologies and recommend future pharmacopoeial initiatives in advanced therapies

Essential Qualification

Master's Degree in Biotechnology, Molecular Biology, Cell Biology, Genetic Engineering, Pharmaceutical Biotechnology, Life Sciences, Genomics, Pharmacy (M.Pharm), Regulatory Sciences, or equivalent from a recognized University/Institute.

Essential Experience

• Minimum 1 years of experience in Cell and Gene Therapy (CGT), Advanced Therapy Medicinal Products (ATMPs), regenerative medicine, tissue engineered products, stem cell products, viral vector-based products, gene-editing technologies, or related biological products.

• Experience in preparation, review, or implementation of quality standards, specifications, analytical methods, regulatory dossiers, pharmacopoeial monographs, or guidelines related to CGT products.

• Working knowledge of national and international regulatory frameworks including CDSCO, ICH, WHO, US FDA, EMA, USP, EP, and other relevant pharmacopoeias.

• Experience in analytical characterization and quality evaluation of CGT products.

Desirable Experience

• Experience in drafting pharmacopoeial monographs, general chapters, guidance documents, or regulatory standards.

• Experience in viral vector characterization, cell-based assays, molecular biology techniques, next-generation sequencing (NGS), flow cytometry, qPCR/ddPCR, potency assays, and sterility/mycoplasma testing.

• Publications, patents, or research work related to CGT products.

• Development and revision of Indian Pharmacopoeia standards such as general requirements, monographs and general chapters related to Cell and Gene Therapy Products.

• Review of national and international guidelines, pharmacopoeial texts, and regulatory requirements.

• Coordination with Expert Working Groups and stakeholders.

• Scientific literature review and analysis for emerging CGT technologies.

• Support analytical method development, verification, and standard-setting activities.