Asst. General Manager - Formulation & Development SAVA HEALTHCARE LIMITED

5.0 - 10.0 years

0 Lacs

maharashtra

On-site

The Assistant General Manager - Nasal Spray Formulation Development will play a crucial role in leading the development of innovative nasal spray formulations within the Research & Development (R&D) department of a Pharmaceuticals company. Reporting to the Head of R&D, you will be responsible for driving projects from concept to commercial scale-up, ensuring regulatory compliance and meeting quality standards. Your primary focus will be on designing, developing, and optimizing nasal spray drug products for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Conduct literature search reports for drug substances and products, design product development strategies, and propose different formulation strategies based on the review outcomes. - Guide executives in lab development batches, provide expert input into formulation and process studies, and ensure compliance with specifications. - Evaluate packaging material vendors, monitor stability studies, and prepare/review Technology Transfer documents. - Coordinate with internal stakeholders, follow GLP & GMP, participate in stability and validation batch manufacturing, and prepare PDR for regulatory submission. Qualifications & Skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. - Specialization in drug delivery systems or formulation science preferred. Experience: - 8-10 years of formulation development experience, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Proven experience in nasal spray product development from early-stage to commercial scale-up. Technical Expertise: - Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience with device development and knowledge of regulatory requirements for nasal spray formulations. Project Management: - Strong project management skills, ability to manage multiple projects, work with cross-functional teams, and deliver results. Regulatory Knowledge: - Experience in preparing and reviewing regulatory submissions, familiarity with CMC requirements for nasal formulations. Leadership & Communication: - Ability to lead and develop a team, excellent communication and presentation skills for conveying complex scientific information. Problem-Solving & Innovation: - Strong analytical and problem-solving skills, ability to innovate and apply new technologies to improve drug delivery processes. Work Environment: - Primarily based at the R&D center with occasional travel to manufacturing sites, vendors, and regulatory meetings. Join us in this exciting role to contribute towards developing high-quality nasal spray formulations for global markets.,

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