R&D Manager - NDDS

About the job

Job Description: The R&D Manager - NDDS will lead formulation and development of novel drug delivery systems, from concept to scale up and tech transfer, ensuring compliance with regulatory and quality standards and alignment with business goals. The role requires strong scientific depth in NDDS, team leadership and cross functional collaboration with QA, RA, manufacturing, BD and marketing. Key responsibilities - Lead end to end development of NDDS formulations (e.g., sustained/ controlled release, transdermal, nano/colloidal systems, injectables, inhalation, etc.) from pre‑formulation to commercialization. - Design and execute formulation and process development experiments, DoE/QbD studies, stability studies, and scale‑up/tech transfer to manufacturing. - Prepare and review development reports, product development dossiers, technology transfer documents, and CMC sections for regulatory submissions. - Establish and optimize analytical methods in collaboration with the analytical team to support formulation development and stability. - Evaluate literature, patents, and market/technology trends to identify new NDDS platforms, line extensions, and lifecycle management opportunities. - Manage multiple R&D projects simultaneously, define timelines, deliverables and resources, and track progress against milestones. - Collaborate closely with cross functional teams (Regulatory, QA, Manufacturing, Supply Chain, BD, Medical) to ensure smooth progression of projects. - Ensure adherence to cGMP, GLP, data integrity, and applicable regulatory guidelines (e.g., ICH, USFDA, EMA, CDSCO as applicable). - Develop and implement lab SOPs to ensure proper documentation and maintenance of development records and databases. - Lead, coach and develop the R&D NDDS team to drive a culture of innovation, scientific rigor and continuous improvement.

Requirements

• Formulation Development
• NDDS
• Regulatory Compliance
• Team Leadership

Qualifications

• M.Pharm
• PhD in Pharmaceutics
• Pharmaceutical Technology

Preferred Technologies

• Formulation Development
• NDDS
• Regulatory Compliance
• Team Leadership