02 Oct
|
Felix Pharmaceuticals
|
Karamba
02 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 - Formulation Research & Development (Karamba)
🏢 Felix Pharmaceuticals
📍 Karamba