Research Associate - PDL OSD

Intas; Ahmedabad District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Intas is seeking a Process Development Laboratory professional to execute development activities for OSD products, including tablets, capsules, granules, and coated formulations. The role involves optimization, scale-up, and technology transfer from R&D to manufacturing, along with documentation and regulatory support.

The candidate will collaborate with Formulation Development, Analytical Development, Manufacturing, QA/QC, Regulatory Affairs, and Engineering teams while ensuring cGMP compliance

Qualifications

• 3–6 years of experience in Process Development Laboratory (PDL) for OSD products within a pharmaceutical company.
• Exposure to technology transfer, exhibit batches, scale-up activities, and commercial manufacturing support.
• Experience with regulated market products (USFDA, EU, MHRA, ROW) preferred.

Responsibilities

• Execute process development activities for tablets, capsules, granules, and coated products.
• Perform process optimization studies for blending, granulation, compression, coating, and encapsulation.
• Conduct scale-up, pilot, exhibit, and validation batches.
• Support technology transfer activities from R&D to manufacturing sites.
• Investigate process-related issues during development, exhibit, and commercial batches.
• Review batch records, manufacturing instructions, and process-related documentation.
• Prepare development reports, risk assessments, protocols, and technical justifications.
• Analyze process data and identify CPPs and CQAs.
• Coordinate with Formulation Development, Analytical Development, Manufacturing, QA, QC, Regulatory Affairs, and Engineering teams.
• Support regulatory submissions by providing process development documentation.
• Ensure compliance with cGMP, Data Integrity, GDP, and EHS requirements.

Skills

OSD manufacturing processes

Wet Granulation

Dry Granulation (Roller Compaction)

Direct Compression

Compression

Film Coating

Capsule Filling

Process Validation

Technology Transfer

Scale-up

QbD principles

FBD

RMG

Blender

Compression Machine

Coating Pan

Capsule Filling Machine

DOE

Risk assessment techniques

Regulatory affairs knowledge (USFDA,EU

Tools

FBD

RMG

Blender

Compression Machine

Coating Pan

Capsule Filling Machine

Job description

Role & responsibilities

• Execute process development activities for tablets, capsules, granules, and coated products.
• Perform process optimization studies for blending, granulation, compression, coating, and encapsulation.
• Conduct scale-up, pilot, exhibit, and validation batches.
• Support technology transfer activities from R&D to manufacturing sites.
• Investigate process-related issues during development, exhibit, and commercial batches.
• Review batch records, manufacturing instructions, and process-related documentation.
• Prepare development reports, risk assessments, protocols, and technical justifications.
• Analyze process data and identify critical process parameters (CPPs) and critical quality attributes (CQAs).
• Coordinate with Formulation Development, Analytical Development, Manufacturing, QA, QC, Regulatory Affairs, and Engineering teams.
• Support regulatory submissions by providing process development documentation.
• Ensure compliance with cGMP, Data Integrity, GDP, and EHS requirements.

Required Technical Skills

• Strong knowledge of OSD manufacturing processes.
• Hands-on experience in:
• Wet Granulation
• Dry Granulation (Roller Compaction)
• Direct Compression
• Compression
• Film Coating
• Capsule Filling
• Knowledge of Process Validation, Technology Transfer, Scale-up, and QbD principles.
• Understanding of equipment such as FBD, RMG, Blender, Compression Machine, Coating Pan, and Capsule Filling Machine.
• Familiarity with statistical tools, DOE, and risk assessment techniques.
• Experience in regulated market products (USFDA, EU, MHRA, ROW) preferred.

Desired Competencies

• Process troubleshooting skills
• Analytical and problem-solving ability
• Cross-functional collaboration
• Technical documentation and reporting
• Effective communication and presentation skills
• Project management and execution

Experience

• 03 to 06 years of experience in Process Development Laboratory (PDL) for OSD products within a pharmaceutical company.
• Exposure to technology transfer, exhibit batches, scale-up activities, and commercial manufacturing support.