Research Scientist

DifGen Pharmaceuticals; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

DifGen Pharmaceuticals Pvt Ltd is seeking a qualified M.Pharm professional to lead analytical development activities in R&D. The role focuses on analyzing development, routine and stability samples of transdermal systems and performing comprehensive method validation and transfer tasks to ensure quality and regulatory compliance.

The incumbent will ensure adherence to GLP/GMP, maintain calibration routines, and generate protocol-bound reports, while supporting regulatory inquiries and working

Qualifications

• M.Pharm with first class.
• Very good knowledge in ICH guidelines.
• Very good knowledge in USP General chapters.
• Very good understanding about regulatory expectations.

Responsibilities

• Analyze development, routine and stability samples of transdermal systems.
• Execute method validation activities (Assay, Dissolution, Related substances, IVRT, etc.).
• Execute method verification, method equivalency, deformulation studies, regulatory queries and qualification of working standards.
• Maintain cleanliness and compliance for analytical activities.
• Ensure laboratory safety, good laboratory practices and good manufacturing practices in the lab.
• Uphold good document practices in the lab.
• Perform periodic calibration and daily calibration of instruments/equipment and monitor daily temperature in the lab.
• Prepare reports of protocol-bound studies.
• Execute method transfer at respective locations.
• Conduct investigational analyses in the lab.

Skills

Regulatory knowledge

Education

M.Pharm (First class)

Job description

Job Details Job Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072 Position Type: Full Time Job Shift: Day

• Responsible for analysis of development, routine and stability samples of transdermal system.
• Responsible for execution of Method validation activities (Assay, Dissolution, Related substances, IVRT, etc.)
• Responsible for execution of activities such as Method verification, Method equivalency, deformulation study, Regulatory query and qualification of working standards.
• Responsible for maintaining cleanliness and compliance for analytical activities.
• Responsible for ensuring laboratory safety, Good laboratory practices and good manufacturing practices in the lab.
• Responsible for Good document practices in the lab.
• Responsible for performing periodic calibration, daily calibration of instruments/equipment and daily temperature monitoring in the lab.
• Responsible for preparation of report of protocol bound studies.
• Responsible for execution of Method transfer at respective location.
• Responsible for investigational analysis in the lab.

• M.Pharm1. Very good knowledge in ICH guidelines,
• 2. Very good knowledge in USP General chapters,
• 3. Very good understanding about regulatory expectations.
• 4. Qualified in M. pharm with first class.