Formulation & Development (F&D) OSD

Intas; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Intas is seeking a highly motivated Formulation & Development (F&D) Scientist/Executive for Oral Solid Dosage (OSD) products. The candidate will spearhead formulation development, optimize processes, and manage technology transfer and regulatory documentation for generic products.

Responsibilities include designing and executing lab-scale and registration batches, compiling development reports, and collaborating across Analytical Development, Regulatory Affairs, QA, and Production.

Qualifications

• M.Pharm (Pharmaceutics) with relevant experience.
• 28 years in Formulation & Development of OSD products.
• Hands-on experience in tablet and capsule formulation development.
• Knowledge of QbD, DOE, ICH guidelines, and regulatory requirements for ANDA/ROW markets.
• Experience with granulation, compression, coating, and scale-up activities.
• Good documentation and communication skills.

Responsibilities

• Develop and optimize formulations for tablets, capsules, and multiparticulate dosage forms.
• Conduct pre-formulation, compatibility, and prototype studies.
• Design and execute laboratory-scale and exhibit/registration batches.
• Prepare development reports, protocols, and technical documents.
• Support technology transfer activities to manufacturing sites.
• Perform troubleshooting during scale-up, validation, and commercialization.
• Review analytical data and ensure compliance with regulatory requirements.
• Coordinate with Analytical Development, Regulatory Affairs, QA, and Production teams.

Skills

Formulation Development

DOE

QbD

Regulatory Knowledge

Scale-up

Documentation

Education

M.Pharm (Pharmaceutics)

Job description

We are seeking a highly motivated Formulation & Development (F&D) Scientist/Executive for Oral Solid Dosage (OSD) products. The candidate will be responsible for formulation development, process optimization, technology transfer, and regulatory documentation for generic pharmaceutical products.

Key Responsibilities

• Develop and optimize formulations for tablets, capsules, and multiparticulate dosage forms.
• Conduct pre-formulation, compatibility, and prototype studies.
• Design and execute laboratory-scale and exhibit/registration batches.
• Prepare development reports, protocols, and technical documents.
• Support technology transfer activities to manufacturing sites.
• Perform troubleshooting during scale-up, validation, and commercialization.
• Review analytical data and ensure compliance with regulatory requirements.
• Coordinate with Analytical Development, Regulatory Affairs, QA, and Production teams.

Required Qualifications

• Education: M.Pharm (Pharmaceutics) with relevant experience.
• Experience: 28 years in Formulation & Development of OSD products.
• Hands-on experience in tablet and capsule formulation development.
• Knowledge of QbD, DOE, ICH guidelines, and regulatory requirements for ANDA/ROW markets.
• Experience with granulation, compression, coating, and scale-up activities.
• Good documentation and communication skills.

Desired Skills

• Problem-solving and scientific reasoning.
• Exposure to technology transfer and process validation.
• Strong understanding of excipients and formulation strategies.
• Ability to work in a cross-functional team environment.