Formulation and Development Scientist - Solid Oral

Intas; Ahmedabad District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Intas in Ahmedabad is seeking a formulation development scientist focused on solid oral dosage forms to drive early development and scale-up.

You will work across QA, QC, Production and Regulatory Affairs to ensure compliant documentation and regulatory readiness. The role demands strong knowledge of OSD development, granulation, and DoE, with hands-on experience and regulatory awareness.

Qualifications

• Experience in solid oral formulation development.
• In-depth knowledge of granulation methods and tableting.
• Familiar with scale-up, tech transfer and related documentation.
• Understanding of regulatory requirements (ICH, USFDA, MHRA).
• DoE/QbD knowledge is preferred.

Responsibilities

• Development of solid oral formulations (IR/MR tablets, capsules).
• Execution of pre-formulation studies and compatibility studies.
• Handling of scale-up, exhibit batch & technology transfer activities.
• Preparation of product development reports (PDR), protocols, and documentation.
• Coordination with QA, QC, Production, Regulatory Affairs.
• Troubleshooting during formulation/process development.
• Support for regulatory queries, dossier preparation (ANDA/ROW markets).
• Execution of stability studies and data evaluation.
• Ensuring compliance with cGMP, data integrity, and safety practices.

Skills

OSD formulation development

Granulation techniques

Scale-up & tech transfer

QbD & DoE

ICH guidelines & regulatory knowledge

Analytical & problem-solving

Education

M. Pharm (Pharmaceutics preferred)

Job description

Role & responsibilities

• Development of solid oral formulations (IR/MR tablets, capsules)


• Execution of pre-formulation studies and compatibility studies


• Handling of scale-up, exhibit batch & technology transfer activities


• Preparation of product development reports (PDR), protocols, and documentation


• Coordination with cross-functional teams (QA, QC, Production, Regulatory Affairs)


• Troubleshooting during formulation/process development


• Support for regulatory queries, dossier preparation (ANDA/ROW markets)


• Execution of stability studies and data evaluation


• Ensuring compliance with cGMP, data integrity, and safety practices

• Strong knowledge of OSD formulation development


• Hands-on experience in granulation techniques (Wet/Dry/Direct Compression)


• Experience with equipment: RMG, FBD, Compression machine, Coating pan


• Understanding of QbD concepts, DoE (preferred)

• Knowledge of ICH guidelines, regulatory requirements (USFDA, MHRA, etc.)


• Good analytical and problem-solving skills

Preferred candidate profile

Educational Qualification

• M. Pharm (Pharmaceutics preferred)

Key Deliverables

• Formulation development within defined timelines


• Successful scale-up and tech transfer


• Accurate and compliant documentation


• Regulatory submission readiness