Asst. General Manager - Formulation & Development (Nasal Spray)

As the Assistant General Manager for Nasal Spray Formulation Development in the Research & Development department at the R&D Center in Chinchwad, Pune, you will be responsible for leading the development of innovative nasal spray formulations. Your role will involve steering projects from concept to commercial scale-up, focusing on designing, developing, and optimizing nasal spray drug products to ensure regulatory compliance and meet quality standards. You will be leading a team of formulation scientists and collaborating with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Your key responsibilities will include: - Developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Preparing and reviewing literature search reports for drug substances and products, and designing product development strategies based on the findings. - Planning and guiding executives for development batches in the lab, ensuring compliance with SOPs. - Providing expert input into formulation and process studies to ensure product compliance with specifications. - Ensuring formulations and processes designed at R&D scale are capable of scale-up and technical transfer to GMP facilities. - Evaluating alternate vendors for packaging material selection and monitoring stability studies. - Preparing/reviewing Technology Transfer documents and coordinating with all stakeholders within the organization. - Following Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP) and participating in stability and validation batch manufacturing. - Preparing Product Development Reports for regulatory submission and drug product approval. You should possess the following qualifications and skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or a related field, with a specialization in drug delivery systems or formulation science preferred. - 8-10 years of hands-on experience in formulation development, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Strong technical expertise in nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience in project management, working with cross-functional teams, and managing regulatory requirements. - Proven leadership abilities, excellent communication skills, and strong problem-solving capabilities. This role will require you to be primarily based at the R&D center in Pune, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,