24 Oct
|
Felix Pharmaceuticals
|
Karamba
24 Oct
Felix Pharmaceuticals
Karamba
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 regulatory queries.
• Facilitate effective technical communication between internal teams and external development/manufacturing partners. Education &
Experience:
• M.
Pharm / M.
S. / Ph.
D. in Pharmaceutics, Pharmaceutical Technology or related discipline.
• 12–16 years of relevant experience in Formulation R&D;/Product Development.
• Solid hands-on experience in OSD formulation development.
• Experience in providing technical oversight to CMO/CRO development activities.
• Experience in scale-up, technology transfer and manufacturing support preferred.
📌 Senior Manager/ AGM (Karamba)
🏢 Felix Pharmaceuticals
📍 Karamba