Research Associate - Analytical R&D

Difgen Pharmaceuticals; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Difgen Pharmaceuticals is seeking a Research Associate Analytical R&D with expertise in Formulation Analytical Research & Development and analytical method development for Oral Solid Dosage forms.

You will perform method development for OSDS in soft gel capsules, modified release forms, suspensions and powders, implementing regulatory-compliant analytical approaches and validating methods as required.

Qualifications

• Experience in analytical method development and validation.
• Knowledge of GLP and regulatory requirements.
• Strong documentation and problem-solving skills.

Responsibilities

• Perform analytical method development for OSD formulations.
• Develop methods per regulatory requirements and expectations.
• Analyze development and stability samples (Assay, RS, Dissolution, Residual Solvents).
• Operate HPLC/UPLC, GC/Headspace, UV and FTIR instruments.
• Conduct method validation per applicable guidelines.
• Prepare and review STPs, protocols, reports and related docs.
• Ensure GLP compliance and proper lab procedures.
• Maintain accurate records and timely completion of activities.
• Apply analytical skills to method development and troubleshooting.

Skills

Analytical R&D

Method development

Problem solving

Documentation

GLP knowledge

Tools

HPLC/UPLC

GC/Headspace

UV

FTIR

Job description

We are looking for a Research Associate Analytical R&D with experience in Formulation Analytical Research & Development and analytical method development for Oral Solid Dosage (OSD) formulations.

Key Responsibilities

• Perform analytical method development for Oral Solid Dosage forms such as Soft Gelatin Capsules, Modified Release Dosage Forms, Oral Suspension, Powder for Oral Suspension, etc.
• Develop analytical methods in accordance with current regulatory requirements and expectations.
• Perform analysis of development and stability samples for parameters including Assay, Related Substances (RS), Dissolution, Residual Solvents and Content.
• Operate analytical instruments such as HPLC/UPLC, GC/Headspace, UV and FTIR.
• Conduct analytical method validation as per applicable guidelines.
• Prepare and review Specifications, Standard Test Procedures (STPs), protocols, analytical reports and related documentation.
• Ensure compliance with Good Laboratory Practices (GLP) and established laboratory procedures.
• Maintain accurate analytical records and ensure timely completion of assigned activities.
• Apply strong analytical and problem-solving skills during method development and troubleshooting.

Required Skills

• Strong knowledge of Pharmaceutical Analysis and Analytical R&D.
• Hands-on experience in HPLC/UPLC, GC/Headspace, UV and FTIR.
• Experience in analytical method development and validation.
• Knowledge of analytical testing of formulation and stability samples.
• Good understanding of GLP and regulatory requirements.Good documentation, analytical and problem-solving skills.