Senior Manager/ AGM– Formulation Research & Development (FRD)

Function: Formulation Research & Development
Level: Senior Manager/ AGM
Location: Greater Noida
Reporting To: Head – R&D; -Formulation Development

Role Purpose:
To provide technical expertise in Formulation Research & Development, with a focus on Oral Solid Dosage (OSD) products, while providing technical support and oversight for CMO and CRO-managed development activities.

Key Responsibilities:
• Lead formulation development activities for OSD products including tablets and capsules.
• Provide technical expertise for formulation design, optimization and process development.
• Plan and review formulation trials, development batches and optimization studies.
• Evaluate formulation and process-related challenges and provide scientifically sound solutions.
• Support scale-up, exhibit batches and technology transfer activities.
• Review stability data and recommend appropriate formulation/process improvements.

Technical Support – CMO & CRO:




• Provide technical guidance and oversight for formulation development activities executed through CMOs and CROs.
• Review technical protocols, development plans, batch documents and development reports.
• Work closely with CMO/CRO technical teams to resolve formulation, process and manufacturing challenges.
• Provide technical inputs during scale-up, exhibit/registration batches and technology transfer.
• Review investigation reports, deviations, change controls and technical documentation related to outsourced activities.
• Ensure timely closure of technical issues and development-related action items.
• Ensure outsourced development activities meet defined technical and quality requirements.

Cross-Functional Collaboration:
• Collaborate closely with Analytical R&D;, Regulatory Affairs, Quality, Manufacturing, API, Supply Chain and other functions.
• Provide technical inputs for CMC documentation and regulatory submissions.
• Support responses to technical and regulat

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