Formulation R&D

3 weeks ago

New Delhi, India RESONACLE Full time

We are seeking a highly skilledFormulation R&D professionalto lead the development oforal drug delivery systems , primarily focusing onsoft gelatin capsules, tablets, and sachets . The role involves driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. The incumbent will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development aligned withregulatory and GMPstandards. The position requires close collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs, while also contributing to innovation and continuous improvement in formulation design.Key Responsibilities: Leadformulation and process developmentfor oral dosage forms—soft gelatin capsules, tablets, and sachets. Plan, design, and executelab-scale and pilot-scale trialsto optimize formulations. Troubleshoot and resolveformulation or process-related challenges . Drivetechnical innovationin formulation design and process improvement. Develop and evaluatestability studiesto finalize product composition. Oversee preparation oftechnical documentation, reports, and batch manufacturing records . Supporttechnology transferactivities from R&D to manufacturing (scale-up and validation). Ensure compliance withGMP, ICH, and regulatory filing requirements(including ANDA submissions for regulated markets). Coordinate with internal and external stakeholders to ensuretimely execution of R&D projects . Providetechnical mentoring and leadershipto the formulation development team.Key Requirements: Education:B.Pharm / M.Pharm (Pharmaceutical Sciences or related field). Experience:Minimum15 yearsin the pharmaceutical industry, preferably inFormulation R&D . Proven experience insoft gelatin capsule and tablet formulation development . Hands-on exposure toANDA filings and regulatory submissionsfor regulated markets. Strong knowledge ofGMP guidelines, formulation design, analytical methods, and scale-up processes . Excellentproblem-solving, leadership, communication, and people managementskills. Ability to work on multiple projects with cross-functional teams.

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