Scientist - Formulation Development (Oral Solid Dosage Forms)

Aurigene Pharmaceutical Services; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Aurigene Pharmaceutical Services in Hyderabad seeks an M.Pharma with 3–8 years in Formulation Development (Solid Orals) to lead development programs, including Wurster coating and granulation, ensuring robust process understanding.

You will drive process development, scale-up, tech transfer, and prepare regulatory documentation (BPRs, SOPs) for QbD studies while collaborating with cross-functional teams to resolve issues and improve manufacturing efficiency, all under cGMP guidelines.

Qualifications

• M.Pharma degree with 3–8 years in Formulation Development (Solid Orals).
• Experience in Wurster coating, process development, scale-up, and tech transfer.
• Familiar with regulatory documentation (BPRs, SOPs) and QbD principles.

Responsibilities

• Develop formulations for solid oral dosage forms, including Wurster coating and granulation.
• Conduct process development, scale-up, and technology transfer for product launches.
• Prepare regulatory documentation for QbD studies.
• Collaborate with cross-functional teams to resolve formulation-related issues and improve efficiency.
• Ensure compliance with cGMP during all formulation development aspects.

Skills

Process Development

Scale-Up

Technology Transfer

Regulatory Documentation

QbD principles

Education

M.Pharma degree

Job description

Roles and Responsibilities

• Develop formulations for solid oral dosage forms, including Wurster coating and granulation processes.
• Conduct process development, scale-up, and technology transfer activities to ensure successful product launches.
• Prepare regulatory documentation such as BPRs, SOPs, and protocols for QbD studies.
• Collaborate with cross-functional teams to resolve formulation-related issues and improve manufacturing efficiency.
• Ensure compliance with cGMP guidelines during all aspects of formulation development.

Desired Candidate Profile

• M.Pharma degree in Any Specialization with 3-8 years of experience in Formulation Development (Solid Orals).
• Strong understanding of Process Development, Scale-Up, Technology Transfer, Regulatory Documentation (BPRs), QbD principles.
• Experience working on Wurster Coating process is essential; knowledge of other solid oral dosage forms like tablets/capsules is desirable.