Officer/Senior Officer- FRD

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore, Madhya Pradesh invites applications for an experienced injectable formulation scientist to lead development projects. The role covers lyophilized injections, complex injectables, lab-scale studies, stability work, and PDR documentation in line with ICH guidelines.

You will collaborate with QA, RA, and Manufacturing, support regulatory submissions with technical data, and contribute to transfer activities while keeping pace with regulatory market requirements.

Qualifications

• Masters in Pharmaceutics, Pharmaceutical Sciences, or related field.
• 5–8 years of hands-on injectable formulation development experience.
• Knowledge of lyophilization techniques and complex injectable formulations.
• Experience in PDR writing and documentation per ICH guidelines.
• Exposure to regulatory market requirements (US, EU, ROW).
• Strong analytical and problem-solving skills.

Responsibilities

• Conduct formulation development for injectable products, including lyophilized injections and complex injectables.
• Perform lab-scale experiments, stability studies, and process optimization.
• Draft and maintain Product Development Reports (PDRs) and other technical documentation.
• Ensure compliance with ICH guidelines and regulatory standards during development.
• Support regulatory submissions by providing technical data and documentation.
• Collaborate with QA, RA, Manufacturing to ensure smooth product development and transfer.
• Stay updated on regulatory requirements and market trends in injectables.

Skills

Formulation development

Analytical skills

Problem-solving

Education

Masters in Pharmaceutics/Pharmaceutical Sciences

Job description

Key Responsibilities

• Conduct formulation development for injectable products, including lyophilized injections and complex injectables.
• Perform lab-scale experiments, stability studies, and process optimization.
• Draft and maintain Product Development Reports (PDRs) and other technical documentation.
• Ensure compliance with ICH guidelines and regulatory standards during development.
• Support regulatory submissions by providing technical data and documentation.
• Collaborate with cross-functional teams (QA, RA, Manufacturing) to ensure smooth product development and transfer.
• Stay updated on regulatory requirements and market trends in injectables.

Qualifications & Experience

• Masters degree in Pharmaceutics, Pharmaceutical Sciences, or related field.
• 5–8 years of hands-on experience in injectable formulation development.
• Practical knowledge of lyophilization techniques and complex injectable formulations.
• Experience in PDR writing and documentation aligned with ICH guidelines.
• Exposure to regulatory market requirements (US, EU, ROW).
• Strong analytical and problem-solving skills.