Senior Manager/ AGM - Formulation Research & Development

Felix Pharmaceuticals Pvt. Ltd.; Varanasi; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Felix Pharmaceuticals Pvt. Ltd. in Greater Noida seeks a Senior Manager/ AGM– FRD to lead oral solid dosage formulation development and provide technical oversight for outsourced development activities with CMOs/CROs.

You will collaborate with analytical, regulatory and manufacturing teams to review protocols, development plans and batch documentation, and support scale-up, stability reviews and technology transfer.

Qualifications

• 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.
• Strong 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.

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.
• 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.
• 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.

Skills

Formulation R&D

OSD development

CMC documentation

Regulatory collaboration

Education

M.Pharm / M.S. / Ph.D. in Pharmaceutics

Job description

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.
• Strong 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.